Management Post-ERCP Removal of Stone in a 76-Year-Old Debilitated Man: Does He Need Cholecystectomy?
Authors: James Y.W. Lau, Joseph J.Y. Sung
Journal: Clinical Gastroenterology and Hepatology (2007)

Clinical ScenarioA 76-year-old debilitated man presented with epigastric pain. His serum biochemistry was as follows: bilirubin level, 3.98 mg/dL (<0.88 mg/dL); alkaline phosphatase level, 361 IU/L (30–80 IU/L); alanine aminotransferase level, 382 IU/L (<58 IU/L), and amylase level, 4709 U/L (28–100 U/L). The hemoglobin level was 10.9 g/dL (11.5–14.3 g/dL), and the total white cell count was 13.2 × 109/L (4–10.8 × 109/L). Endoscopic retrograde cholangiopancreatography (ERCP) showed an impacted stone at the ampulla of Vater (Figure 1). A needle knife sphincterotomy was performed. The stone was disimpacted and the bile duct was decompressed. An ultrasound scan performed during his admission showed multiple small gallstones in a thick-walled gallbladder. Does he need a cholecystectomy?ProblemIn 1901, at a post mortem examination on a patient who died from acute pancreatitis, Opie found an incarcerating stone at the ampulla of Vater. He postulated that the migrated stone from the gallbladder had obstructed bile outflow and that reflux of bile into the pancreatic duct induced pancreatitis. This is the basis for the common-channel theory. With the gallbladder left in situ, recurrent attacks of pancreatitis occur in 30%–50% of patients. Therefore, it would be logical to remove the gallbladder to prevent recurrent attacks.Endoscopic sphincterotomy has taken center stage in the management of common bile duct stones. In patients presenting with acute pancreatitis or cholangitis, endoscopic therapy is the treatment of choice in bile duct decompression. In randomized trials, ERCP was shown to improve patient outcomes. In cohort studies, recurrence of biliary complications after successful endoscopic sphincterotomy and stone removal varied from 4% to 23%. In patients with biliary pancreatitis, sphincter ablation allows free passage of smaller stones and recurrence of pancreatitis is infrequent. The role of routine cholecystectomy has been disputed, especially in elderly patients with significant comorbidities.The effect of endoscopic sphincterotomy on the gallbladder itself is unclear. In a randomized study that compared balloon sphincteroplasty with sphincterotomy, acute cholecystitis occurred in 10% of patients who underwent sphincterotomy. In contrast, acute cholecystitis was not observed among patients after sphincteroplasty. Preserved sphincter function may be important in guarding against reflux of bacteria from the gut lumen into the biliary system. After endoscopic sphincterotomy, it is claimed that gallbladder contractility may improve, and in patients with acute cholecystitis, an endoscopic sphincterotomy can aid in the resolution of acute cholecystitis. Pancreatic trypsin concentrations are high in gallbladder bile taken from cholecystectomy specimens from patients who underwent cholecystectomy for acute cholecystitis. Increased gallbladder trypsin in acute cholecystitis may indicate a functional disorder in the sphincter of Oddi, and could make sphincterotomy a logical procedure to facilitate drainage of injurious pancreatic enzymes as part of the treatment for acute cholecystitis.Acute cholecystitis often is part of an inflammatory process of the biliary tree in someone with cholangitis. In patients with nonfunctioning or diseased gallbladders, infection could be introduced at the time of ERCP, and impaired emptying of the gallbladder then could lead to acute cholecystitis.Management Strategies and Supporting EvidenceWhat are the strategies in managing patients with intact gallbladders and stones after successful endoscopic sphincterotomy and ductal clearance? The obvious strategies are a wait-and-see policy or laparoscopic cholecystectomy. Other options include percutaneous cholecystostomy, medical dissolution therapy, or electrohydraulic shockwave lithotripsy to gallstones; these options are used less frequently.There have been 2 studies that compared a wait-and-see policy with routine laparoscopic cholecystectomy after successful endoscopic sphincterotomy and bile duct stone clearance: the Dutch and the recently published Hong Kong studies. The Dutch study randomized patients between 18 and 80 years of age. Fifty-six patients were randomized to laparoscopic cholecystectomy within 6 weeks of endoscopic sphincterotomy and 64 patients were randomized to expectant management. Patients classified as the American Anesthesiology grading of IV and V were not included in the study. At a median follow-up period of 30 months, 27 of 59 patients (47%) in the expectant management group returned with biliary events. These consisted of biliary pain in 18 patients, acute cholecystitis in 7 patients, jaundice in 1 patient, and biliocutaneous fistula in 1 patient. Of the 27 patients who returned with biliary events, 22 underwent laparoscopic cholecystectomy. Twelve (55%) of these laparoscopic approaches were converted to open surgery. A younger age predicted recurrent biliary events. Of 49 patients assigned to early laparoscopic cholecystectomy, 8 (20%) were converted to open surgery. Postoperative complications developed in 6 (14%) patients. These were mostly wound complications and intra-abdominal abscesses. One patient was found to have a gallbladder carcinoma. The investigators concluded that early laparoscopic cholecystectomy should be recommended after endoscopic sphincterotomy with clearance of the bile duct of stones.The Hong Kong study randomized Chinese patients who were older than 60 years of age. Nearly a third of eligible patients with bile duct stones and contemporaneous gallstones did not enter the study. These patients mostly opted for conservative management. The median follow-up period in the Hong Kong study was 60 months. A total of 178 patients were randomized; 89 patients to both the laparoscopic cholecystectomy and conservative treatment groups. Six of 89 patients in the laparoscopic cholecystectomy group returned with bile duct stones. Among those with gallbladders in situ, 21 patients developed further biliary events. These consisted of recurrent bile duct stones in 14 patients, and acute cholecystitis or biliary colic in 7 patients. At 5 years, the cumulative probability of recurrent biliary events in the cholecystectomy group and gallbladders in situ group was 5.8% and 25.4%, respectively (P = .001). Among patients assigned to elective laparoscopic cholecystectomy, conversion to open surgery was needed in 16 of 82 patients (19.5%). There was a nonsignificant increase in the number of deaths reported during the follow-up evaluation in those with gallbladders left in situ (11 vs 19) (P = .123). Four of 19 late deaths occurred during a recurrent episode of biliary sepsis in those with gallbladder in situ. After cholecystectomy, none of 11 late deaths was related to a biliary cause.The 2 studies differed in the age and ethnicity of the studied populations. The recurrent events in the Dutch study were mostly biliary pain related to gallstones, whereas the recurrent events in the Hong Kong study were related to recurrent bile duct stones. The higher prevalence of primary ductal stones among the Asian population may explain the difference in the mode of recurrences.What have we learned from randomized studies? First, early laparoscopic cholecystectomy confers protection against further biliary events, even among patients thought to have a high prevalence of primary stones. Second, laparoscopic cholecystectomy would be challenging, as evident by a high conversion rate to open surgery in either trial. Delayed surgery would be even more demanding because of scarring of Calot’s triangle (a triangle bounded by the cystic artery, the cystic duct, and the hepatic duct) consequent to recurrent sepsis. In such instances, the conversion rate to open surgery approaches 50%.Based on findings from the 2 studies, we can conclude that in young and good-risk patients (good surgical risk patients without significant comorbidity) with concomitant bile duct stones and gallstones, laparoscopic cholecystectomy should be offered after endoscopic sphincterotomy and bile duct stone clearance. To gain maximal benefit from cholecystectomy, surgery should be performed early.Areas of UncertaintyOn the basis of current knowledge, it is unclear whether it is possible to predict recurrences of biliary events after endoscopic sphincterotomy and clearance of choledocholithiasis.The identification of patients at risk of recurrent biliary events leads to a more selective policy in offering cholecystectomy. Unfortunately, reports on the prediction of future recurrences of biliary events are inconsistent in their findings. Most studies in the literature did not distinguish between recurrent events caused by calculus obstruction at the gallbladder neck or in the bile duct. These 2 modes of recurrences vary in their presentations. Factors in the prediction of gallbladder complications and bile duct stones and related complications are likely to be different. It has been postulated that nonfilling of the gallbladder at the time of ERCP predicts recurrent gallbladder symptoms and complications and, therefore, the need for subsequent cholecystectomy. Some investigators have studied gallbladder function using cholescintigraphy and used it as a guide when offering surgery. However, it also is unclear whether such an assessment of gallbladder function clearly identifies a subgroup at increased risk.Juxtapapillary diverticulum, a markedly dilated bile duct, and multiple or large stones are some of the factors found to predict recurrent bile duct stones. Papillary stenosis from previous incomplete sphincterotomy can be identified endoscopically, and is thought to cause stone recurrence. Occasionally, a biliary stricture or an obstructing lesion can be found that might have been overlooked or have developed in the interim.Perhaps the most consistent factor found to predict recurrent bile duct stones is a markedly dilated bile duct. This would indicate inertia of the bile duct itself and in our experience recurrent stones often are primary pigment stones. There is some evidence in the literature to suggest that checking the serum liver biochemistry every 2–3 months and selected use of ERCP when liver function becomes abnormal may detect recurrent bile duct stones before they lead to complications.Should We Recommend Routine Cholecystectomy in the Very Elderly?In the very elderly and frail patients, a conservative approach may be indicated if cholecystectomy is unlikely to add to the patients’ quality of life. It often is difficult to extrapolate the findings from published studies to individual patients with unique morbidities. First, randomized studies necessarily involve a selection bias. This is evident from a high proportion of elderly patients who were not willing to undergo cholecystectomy or to participate in clinical trials. Second, the published randomized studies consisted of small number of patients, and these studies were not sufficiently powered to detect a difference in death related to recurrent biliary events. Third, the Dutch study suggested that quality of life appears unimpaired based on limited SF-36 measurements, even with gallbladders left in situ. Fourth, if a patient chose to adopt a wait-and-see policy, the odds that he/she would remain symptom free and avoid cholecystectomy is more than 50% at 3 years, based on extrapolation of data from the Dutch study. The odds are even better (75% at 5 years) based on the Hong Kong data. Fifth, recurrent bile duct stones often can be treated adequately by repeat ERCP and with minimal morbidities. Sixth, rates of recurrent biliary events in randomized studies were somewhat higher than in cohort studies. The true incidence of recurrent bile duct stones is unknown. We still require a large prospective cohort study with carefully defined outcome events and a sufficiently long follow-up period to identify patients who will develop recurrences.Is Cholecystectomy Safe in the Very Elderly?Laparoscopic cholecystectomy for complicated gallstone disease is difficult. Costi et al summarized 10 series reporting the use of laparoscopic cholecystectomy among patients older than 75 years of age. The overall mortality rate was 13 of 644 (2%) patients. The mortality rate may be the result of a case mix of mostly patients with symptomatic gallstones. The findings emphasize the fact that judicious selection of patients leads to good results. The timing of laparoscopic cholecystectomy after endoscopic sphincterotomy has not been well studied. Early laparoscopic cholecystectomy may be easier before the inflammatory process has progressed to the point of problematic adhesions and scarring.Residual or Recurrent Biliary DiseaseThe majority of recurrent biliary events take place within the first year of endoscopic sphincterotomy and clearance of choledocholithiasis. In fact, it can be difficult to distinguish recurrence or residual disease. In the event of bile duct stones, complete stone clearance is difficult to assure even on occlusion cholangiogram, especially in patients with dilated ducts. Magnetic resonance cholangiopancreatography, endosonography, or cholangioscopy may provide useful information. More studies are required.In the Hong Kong study, 10% of patients who underwent surgery near the time of endoscopic sphincterotomy were found to have acute cholecystitis during laparoscopy. If a patient develops cholecystitis shortly after endoscopic sphincterotomy, it could be a co-existing disease that was resolved incompletely.Published GuidelinesAll published guidelines endorse a policy of cholecystectomy for complicated gallstone disease. However, none made specific reference to the need for cholecystectomy after endoscopic sphincterotomy for bile duct stones. It is implicit that endoscopic sphincterotomy is not definitive in patients with both cholelithiasis and choledocholithiasis. The Society of Surgeons of the Alimentary Tract guidelines state that gallstone pancreatitis, choledocholithiasis, and cholangitis require immediate surgical consultation. The guidelines further state that common bile duct stones may be removed either endoscopically or surgically and that, because most common bile duct stones arise from the gallbladder, cholecystectomy also is indicated during surgical exploration of the common bile duct. The American College of Physicians guidelines for the treatment of gallstones published a decade ago recommended that: “Symptomatic patients who opt for expectant management would have to believe that the gains from prophylactic cholecystectomy, in terms of life expectancy, do not warrant intervention. For such patients, the decision between immediate treatment or expectant management may be more a matter of personal choice and convenience.”RecommendationsA clinician would be tempted to dismiss an elderly debilitated patient after successful endoscopic treatment of their bile duct stones (Figure 2). The algorithm in Figure 1 reflects on experience and the published literature. The existing literature suggests that laparoscopic cholecystectomy would reduce gallstone complications further. It would be prudent first to ask if bile duct stones have migrated from the gallbladder. Soft-pigment stones are formed primarily within the bile duct, whereas cholesterol stones are more likely to have migrated from the gallbladder. Is there concomitant pathology such as a bile duct stricture that was treated adequately? The presence of an intrahepatic ductal stricture would implicate primary cholangitis. Were there gallstones or other features in the gallbladder that warranted intervention? A thick-walled gallbladder, the presence of a polypoid lesion greater than 1 cm in size, or a porcelain gallbladder with thick bile containing calcium would otherwise mandate cholecystectomy. It would be prudent to review the patient’s medical history and to determine if his comorbidities could be optimized further. A surgical consultation certainly should be initiated within the same admission. The patient can be better informed on the probability of recurrences, extrapolating from the published studies thus far and take into account the surgeon’s experience. A decision then can be made in light of the other medical comorbidities and life expectancy of the individual patient (Figure 1).Figure 2(A) A small whitish stone was found impacting on the ampulla of Vater during ERCP. (B) An incision was made into the bulging papilla using a needle knife. (C) The stone passed after the incision. (D) The bile duct was decompressed.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Clinical ScenarioA 76-year-old debilitated man presented with epigastric pain. His serum biochemistry was as follows: bilirubin level, 3.98 mg/dL (<0.88 mg/dL); alkaline phosphatase level, 361 IU/L (30–80 IU/L); alanine aminotransferase level, 382 IU/L (<58 IU/L), and amylase level, 4709 U/L (28–100 U/L). The hemoglobin level was 10.9 g/dL (11.5–14.3 g/dL), and the total white cell count was 13.2 × 109/L (4–10.8 × 109/L). Endoscopic retrograde cholangiopancreatography (ERCP) showed an impacted stone at the ampulla of Vater (Figure 1). A needle knife sphincterotomy was performed. The stone was disimpacted and the bile duct was decompressed. An ultrasound scan performed during his admission showed multiple small gallstones in a thick-walled gallbladder. Does he need a cholecystectomy? A 76-year-old debilitated man presented with epigastric pain. His serum biochemistry was as follows: bilirubin level, 3.98 mg/dL (<0.88 mg/dL); alkaline phosphatase level, 361 IU/L (30–80 IU/L); alanine aminotransferase level, 382 IU/L (<58 IU/L), and amylase level, 4709 U/L (28–100 U/L). The hemoglobin level was 10.9 g/dL (11.5–14.3 g/dL), and the total white cell count was 13.2 × 109/L (4–10.8 × 109/L). Endoscopic retrograde cholangiopancreatography (ERCP) showed an impacted stone at the ampulla of Vater (Figure 1). A needle knife sphincterotomy was performed. The stone was disimpacted and the bile duct was decompressed. An ultrasound scan performed during his admission showed multiple small gallstones in a thick-walled gallbladder. Does he need a cholecystectomy? ProblemIn 1901, at a post mortem examination on a patient who died from acute pancreatitis, Opie found an incarcerating stone at the ampulla of Vater. He postulated that the migrated stone from the gallbladder had obstructed bile outflow and that reflux of bile into the pancreatic duct induced pancreatitis. This is the basis for the common-channel theory. With the gallbladder left in situ, recurrent attacks of pancreatitis occur in 30%–50% of patients. Therefore, it would be logical to remove the gallbladder to prevent recurrent attacks.Endoscopic sphincterotomy has taken center stage in the management of common bile duct stones. In patients presenting with acute pancreatitis or cholangitis, endoscopic therapy is the treatment of choice in bile duct decompression. In randomized trials, ERCP was shown to improve patient outcomes. In cohort studies, recurrence of biliary complications after successful endoscopic sphincterotomy and stone removal varied from 4% to 23%. In patients with biliary pancreatitis, sphincter ablation allows free passage of smaller stones and recurrence of pancreatitis is infrequent. The role of routine cholecystectomy has been disputed, especially in elderly patients with significant comorbidities.The effect of endoscopic sphincterotomy on the gallbladder itself is unclear. In a randomized study that compared balloon sphincteroplasty with sphincterotomy, acute cholecystitis occurred in 10% of patients who underwent sphincterotomy. In contrast, acute cholecystitis was not observed among patients after sphincteroplasty. Preserved sphincter function may be important in guarding against reflux of bacteria from the gut lumen into the biliary system. After endoscopic sphincterotomy, it is claimed that gallbladder contractility may improve, and in patients with acute cholecystitis, an endoscopic sphincterotomy can aid in the resolution of acute cholecystitis. Pancreatic trypsin concentrations are high in gallbladder bile taken from cholecystectomy specimens from patients who underwent cholecystectomy for acute cholecystitis. Increased gallbladder trypsin in acute cholecystitis may indicate a functional disorder in the sphincter of Oddi, and could make sphincterotomy a logical procedure to facilitate drainage of injurious pancreatic enzymes as part of the treatment for acute cholecystitis.Acute cholecystitis often is part of an inflammatory process of the biliary tree in someone with cholangitis. In patients with nonfunctioning or diseased gallbladders, infection could be introduced at the time of ERCP, and impaired emptying of the gallbladder then could lead to acute cholecystitis. In 1901, at a post mortem examination on a patient who died from acute pancreatitis, Opie found an incarcerating stone at the ampulla of Vater. He postulated that the migrated stone from the gallbladder had obstructed bile outflow and that reflux of bile into the pancreatic duct induced pancreatitis. This is the basis for the common-channel theory. With the gallbladder left in situ, recurrent attacks of pancreatitis occur in 30%–50% of patients. Therefore, it would be logical to remove the gallbladder to prevent recurrent attacks. Endoscopic sphincterotomy has taken center stage in the management of common bile duct stones. In patients presenting with acute pancreatitis or cholangitis, endoscopic therapy is the treatment of choice in bile duct decompression. In randomized trials, ERCP was shown to improve patient outcomes. In cohort studies, recurrence of biliary complications after successful endoscopic sphincterotomy and stone removal varied from 4% to 23%. In patients with biliary pancreatitis, sphincter ablation allows free passage of smaller stones and recurrence of pancreatitis is infrequent. The role of routine cholecystectomy has been disputed, especially in elderly patients with significant comorbidities. The effect of endoscopic sphincterotomy on the gallbladder itself is unclear. In a randomized study that compared balloon sphincteroplasty with sphincterotomy, acute cholecystitis occurred in 10% of patients who underwent sphincterotomy. In contrast, acute cholecystitis was not observed among patients after sphincteroplasty. Preserved sphincter function may be important in guarding against reflux of bacteria from the gut lumen into the biliary system. After endoscopic sphincterotomy, it is claimed that gallbladder contractility may improve, and in patients with acute cholecystitis, an endoscopic sphincterotomy can aid in the resolution of acute cholecystitis. Pancreatic trypsin concentrations are high in gallbladder bile taken from cholecystectomy specimens from patients who underwent cholecystectomy for acute cholecystitis. Increased gallbladder trypsin in acute cholecystitis may indicate a functional disorder in the sphincter of Oddi, and could make sphincterotomy a logical procedure to facilitate drainage of injurious pancreatic enzymes as part of the treatment for acute cholecystitis. Acute cholecystitis often is part of an inflammatory process of the biliary tree in someone with cholangitis. In patients with nonfunctioning or diseased gallbladders, infection could be introduced at the time of ERCP, and impaired emptying of the gallbladder then could lead to acute cholecystitis. Management Strategies and Supporting EvidenceWhat are the strategies in managing patients with intact gallbladders and stones after successful endoscopic sphincterotomy and ductal clearance? The obvious strategies are a wait-and-see policy or laparoscopic cholecystectomy. Other options include percutaneous cholecystostomy, medical dissolution therapy, or electrohydraulic shockwave lithotripsy to gallstones; these options are used less frequently.There have been 2 studies that compared a wait-and-see policy with routine laparoscopic cholecystectomy after successful endoscopic sphincterotomy and bile duct stone clearance: the Dutch and the recently published Hong Kong studies. The Dutch study randomized patients between 18 and 80 years of age. Fifty-six patients were randomized to laparoscopic cholecystectomy within 6 weeks of endoscopic sphincterotomy and 64 patients were randomized to expectant management. Patients classified as the American Anesthesiology grading of IV and V were not included in the study. At a median follow-up period of 30 months, 27 of 59 patients (47%) in the expectant management group returned with biliary events. These consisted of biliary pain in 18 patients, acute cholecystitis in 7 patients, jaundice in 1 patient, and biliocutaneous fistula in 1 patient. Of the 27 patients who returned with biliary events, 22 underwent laparoscopic cholecystectomy. Twelve (55%) of these laparoscopic approaches were converted to open surgery. A younger age predicted recurrent biliary events. Of 49 patients assigned to early laparoscopic cholecystectomy, 8 (20%) were converted to open surgery. Postoperative complications developed in 6 (14%) patients. These were mostly wound complications and intra-abdominal abscesses. One patient was found to have a gallbladder carcinoma. The investigators concluded that early laparoscopic cholecystectomy should be recommended after endoscopic sphincterotomy with clearance of the bile duct of stones.The Hong Kong study randomized Chinese patients who were older than 60 years of age. Nearly a third of eligible patients with bile duct stones and contemporaneous gallstones did not enter the study. These patients mostly opted for conservative management. The median follow-up period in the Hong Kong study was 60 months. A total of 178 patients were randomized; 89 patients to both the laparoscopic cholecystectomy and conservative treatment groups. Six of 89 patients in the laparoscopic cholecystectomy group returned with bile duct stones. Among those with gallbladders in situ, 21 patients developed further biliary events. These consisted of recurrent bile duct stones in 14 patients, and acute cholecystitis or biliary colic in 7 patients. At 5 years, the cumulative probability of recurrent biliary events in the cholecystectomy group and gallbladders in situ group was 5.8% and 25.4%, respectively (P = .001). Among patients assigned to elective laparoscopic cholecystectomy, conversion to open surgery was needed in 16 of 82 patients (19.5%). There was a nonsignificant increase in the number of deaths reported during the follow-up evaluation in those with gallbladders left in situ (11 vs 19) (P = .123). Four of 19 late deaths occurred during a recurrent episode of biliary sepsis in those with gallbladder in situ. After cholecystectomy, none of 11 late deaths was related to a biliary cause.The 2 studies differed in the age and ethnicity of the studied populations. The recurrent events in the Dutch study were mostly biliary pain related to gallstones, whereas the recurrent events in the Hong Kong study were related to recurrent bile duct stones. The higher prevalence of primary ductal stones among the Asian population may explain the difference in the mode of recurrences.What have we learned from randomized studies? First, early laparoscopic cholecystectomy confers protection against further biliary events, even among patients thought to have a high prevalence of primary stones. Second, laparoscopic cholecystectomy would be challenging, as evident by a high conversion rate to open surgery in either trial. Delayed surgery would be even more demanding because of scarring of Calot’s triangle (a triangle bounded by the cystic artery, the cystic duct, and the hepatic duct) consequent to recurrent sepsis. In such instances, the conversion rate to open surgery approaches 50%.Based on findings from the 2 studies, we can conclude that in young and good-risk patients (good surgical risk patients without significant comorbidity) with concomitant bile duct stones and gallstones, laparoscopic cholecystectomy should be offered after endoscopic sphincterotomy and bile duct stone clearance. To gain maximal benefit from cholecystectomy, surgery should be performed early. What are the strategies in managing patients with intact gallbladders and stones after successful endoscopic sphincterotomy and ductal clearance? The obvious strategies are a wait-and-see policy or laparoscopic cholecystectomy. Other options include percutaneous cholecystostomy, medical dissolution therapy, or electrohydraulic shockwave lithotripsy to gallstones; these options are used less frequently. There have been 2 studies that compared a wait-and-see policy with routine laparoscopic cholecystectomy after successful endoscopic sphincterotomy and bile duct stone clearance: the Dutch and the recently published Hong Kong studies. The Dutch study randomized patients between 18 and 80 years of age. Fifty-six patients were randomized to laparoscopic cholecystectomy within 6 weeks of endoscopic sphincterotomy and 64 patients were randomized to expectant management. Patients classified as the American Anesthesiology grading of IV and V were not included in the study. At a median follow-up period of 30 months, 27 of 59 patients (47%) in the expectant management group returned with biliary events. These consisted of biliary pain in 18 patients, acute cholecystitis in 7 patients, jaundice in 1 patient, and biliocutaneous fistula in 1 patient. Of the 27 patients who returned with biliary events, 22 underwent laparoscopic cholecystectomy. Twelve (55%) of these laparoscopic approaches were converted to open surgery. A younger age predicted recurrent biliary events. Of 49 patients assigned to early laparoscopic cholecystectomy, 8 (20%) were converted to open surgery. Postoperative complications developed in 6 (14%) patients. These were mostly wound complications and intra-abdominal abscesses. One patient was found to have a gallbladder carcinoma. The investigators concluded that early laparoscopic cholecystectomy should be recommended after endoscopic sphincterotomy with clearance of the bile duct of stones. The Hong Kong study randomized Chinese patients who were older than 60 years of age. Nearly a third of eligible patients with bile duct stones and contemporaneous gallstones did not enter the study. These patients mostly opted for conservative management. The median follow-up period in the Hong Kong study was 60 months. A total of 178 patients were randomized; 89 patients to both the laparoscopic cholecystectomy and conservative treatment groups. Six of 89 patients in the laparoscopic cholecystectomy group returned with bile duct stones. Among those with gallbladders in situ, 21 patients developed further biliary events. These consisted of recurrent bile duct stones in 14 patients, and acute cholecystitis or biliary colic in 7 patients. At 5 years, the cumulative probability of recurrent biliary events in the cholecystectomy group and gallbladders in situ group was 5.8% and 25.4%, respectively (P = .001). Among patients assigned to elective laparoscopic cholecystectomy, conversion to open surgery was needed in 16 of 82 patients (19.5%). There was a nonsignificant increase in the number of deaths reported during the follow-up evaluation in those with gallbladders left in situ (11 vs 19) (P = .123). Four of 19 late deaths occurred during a recurrent episode of biliary sepsis in those with gallbladder in situ. After cholecystectomy, none of 11 late deaths was related to a biliary cause. The 2 studies differed in the age and ethnicity of the studied populations. The recurrent events in the Dutch study were mostly biliary pain related to gallstones, whereas the recurrent events in the Hong Kong study were related to recurrent bile duct stones. The higher prevalence of primary ductal stones among the Asian population may explain the difference in the mode of recurrences. What have we learned from randomized studies? First, early laparoscopic cholecystectomy confers protection against further biliary events, even among patients thought to have a high prevalence of primary stones. Second, laparoscopic cholecystectomy would be challenging, as evident by a high conversion rate to open surgery in either trial. Delayed surgery would be even more demanding because of scarring of Calot’s triangle (a triangle bounded by the cystic artery, the cystic duct, and the hepatic duct) consequent to recurrent sepsis. In such instances, the conversion rate to open surgery approaches 50%. Based on findings from the 2 studies, we can conclude that in young and good-risk patients (good surgical risk patients without significant comorbidity) with concomitant bile duct stones and gallstones, laparoscopic cholecystectomy should be offered after endoscopic sphincterotomy and bile duct stone clearance. To gain maximal benefit from cholecystectomy, surgery should be performed early. Areas of UncertaintyOn the basis of current knowledge, it is unclear whether it is possible to predict recurrences of biliary events after endoscopic sphincterotomy and clearance of choledocholithiasis.The identification of patients at risk of recurrent biliary events leads to a more selective policy in offering cholecystectomy. Unfortunately, reports on the prediction of future recurrences of biliary events are inconsistent in their findings. Most studies in the literature did not distinguish between recurrent events caused by calculus obstruction at the gallbladder neck or in the bile duct. These 2 modes of recurrences vary in their presentations. Factors in the prediction of gallbladder complications and bile duct stones and related complications are likely to be different. It has been postulated that nonfilling of the gallbladder at the time of ERCP predicts recurrent gallbladder symptoms and complications and, therefore, the need for subsequent cholecystectomy. Some investigators have studied gallbladder function using cholescintigraphy and used it as a guide when offering surgery. However, it also is unclear whether such an assessment of gallbladder function clearly identifies a subgroup at increased risk.Juxtapapillary diverticulum, a markedly dilated bile duct, and multiple or large stones are some of the factors found to predict recurrent bile duct stones. Papillary stenosis from previous incomplete sphincterotomy can be identified endoscopically, and is thought to cause stone recurrence. Occasionally, a biliary stricture or an obstructing lesion can be found that might have been overlooked or have developed in the interim.Perhaps the most consistent factor found to predict recurrent bile duct stones is a markedly dilated bile duct. This would indicate inertia of the bile duct itself and in our experience recurrent stones often are primary pigment stones. There is some evidence in the literature to suggest that checking the serum liver biochemistry every 2–3 months and selected use of ERCP when liver function becomes abnormal may detect recurrent bile duct stones before they lead to complications.Should We Recommend Routine Cholecystectomy in the Very Elderly?In the very elderly and frail patients, a conservative approach may be indicated if cholecystectomy is unlikely to add to the patients’ quality of life. It often is difficult to extrapolate the findings from published studies to individual patients with unique morbidities. First, randomized studies necessarily involve a selection bias. This is evident from a high proportion of elderly patients who were not willing to undergo cholecystectomy or to participate in clinical trials. Second, the published randomized studies consisted of small number of patients, and these studies were not sufficiently powered to detect a difference in death related to recurrent biliary events. Third, the Dutch study suggested that quality of life appears unimpaired based on limited SF-36 measurements, even with gallbladders left in situ. Fourth, if a patient chose to adopt a wait-and-see policy, the odds that he/she would remain symptom free and avoid cholecystectomy is more than 50% at 3 years, based on extrapolation of data from the Dutch study. The odds are even better (75% at 5 years) based on the Hong Kong data. Fifth, recurrent bile duct stones often can be treated adequately by repeat ERCP and with minimal morbidities. Sixth, rates of recurrent biliary events in randomized studies were somewhat higher than in cohort studies. The true incidence of recurrent bile duct stones is unknown. We still require a large prospective cohort study with carefully defined outcome events and a sufficiently long follow-up period to identify patients who will develop recurrences.Is Cholecystectomy Safe in the Very Elderly?Laparoscopic cholecystectomy for complicated gallstone disease is difficult. Costi et al summarized 10 series reporting the use of laparoscopic cholecystectomy among patients older than 75 years of age. The overall mortality rate was 13 of 644 (2%) patients. The mortality rate may be the result of a case mix of mostly patients with symptomatic gallstones. The findings emphasize the fact that judicious selection of patients leads to good results. The timing of laparoscopic cholecystectomy after endoscopic sphincterotomy has not been well studied. Early laparoscopic cholecystectomy may be easier before the inflammatory process has progressed to the point of problematic adhesions and scarring.Residual or Recurrent Biliary DiseaseThe majority of recurrent biliary events take place within the first year of endoscopic sphincterotomy and clearance of choledocholithiasis. In fact, it can be difficult to distinguish recurrence or residual disease. In the event of bile duct stones, complete stone clearance is difficult to assure even on occlusion cholangiogram, especially in patients with dilated ducts. Magnetic resonance cholangiopancreatography, endosonography, or cholangioscopy may provide useful information. More studies are required.In the Hong Kong study, 10% of patients who underwent surgery near the time of endoscopic sphincterotomy were found to have acute cholecystitis during laparoscopy. If a patient develops cholecystitis shortly after endoscopic sphincterotomy, it could be a co-existing disease that was resolved incompletely. On the basis of current knowledge, it is unclear whether it is possible to predict recurrences of biliary events after endoscopic sphincterotomy and clearance of choledocholithiasis. The identification of patients at risk of recurrent biliary events leads to a more selective policy in offering cholecystectomy. Unfortunately, reports on the prediction of future recurrences of biliary events are inconsistent in their findings. Most studies in the literature did not distinguish between recurrent events caused by calculus obstruction at the gallbladder neck or in the bile duct. These 2 modes of recurrences vary in their presentations. Factors in the prediction of gallbladder complications and bile duct stones and related complications are likely to be different. It has been postulated that nonfilling of the gallbladder at the time of ERCP predicts recurrent gallbladder symptoms and complications and, therefore, the need for subsequent cholecystectomy. Some investigators have studied gallbladder function using cholescintigraphy and used it as a guide when offering surgery. However, it also is unclear whether such an assessment of gallbladder function clearly identifies a subgroup at increased risk. Juxtapapillary diverticulum, a markedly dilated bile duct, and multiple or large stones are some of the factors found to predict recurrent bile duct stones. Papillary stenosis from previous incomplete sphincterotomy can be identified endoscopically, and is thought to cause stone recurrence. Occasionally, a biliary stricture or an obstructing lesion can be found that might have been overlooked or have developed in the interim. Perhaps the most consistent factor found to predict recurrent bile duct stones is a markedly dilated bile duct. This would indicate inertia of the bile duct itself and in our experience recurrent stones often are primary pigment stones. There is some evidence in the literature to suggest that checking the serum liver biochemistry every 2–3 months and selected use of ERCP when liver function becomes abnormal may detect recurrent bile duct stones before they lead to complications. Should We Recommend Routine Cholecystectomy in the Very Elderly?In the very elderly and frail patients, a conservative approach may be indicated if cholecystectomy is unlikely to add to the patients’ quality of life. It often is difficult to extrapolate the findings from published studies to individual patients with unique morbidities. First, randomized studies necessarily involve a selection bias. This is evident from a high proportion of elderly patients who were not willing to undergo cholecystectomy or to participate in clinical trials. Second, the published randomized studies consisted of small number of patients, and these studies were not sufficiently powered to detect a difference in death related to recurrent biliary events. Third, the Dutch study suggested that quality of life appears unimpaired based on limited SF-36 measurements, even with gallbladders left in situ. Fourth, if a patient chose to adopt a wait-and-see policy, the odds that he/she would remain symptom free and avoid cholecystectomy is more than 50% at 3 years, based on extrapolation of data from the Dutch study. The odds are even better (75% at 5 years) based on the Hong Kong data. Fifth, recurrent bile duct stones often can be treated adequately by repeat ERCP and with minimal morbidities. Sixth, rates of recurrent biliary events in randomized studies were somewhat higher than in cohort studies. The true incidence of recurrent bile duct stones is unknown. We still require a large prospective cohort study with carefully defined outcome events and a sufficiently long follow-up period to identify patients who will develop recurrences. In the very elderly and frail patients, a conservative approach may be indicated if cholecystectomy is unlikely to add to the patients’ quality of life. It often is difficult to extrapolate the findings from published studies to individual patients with unique morbidities. First, randomized studies necessarily involve a selection bias. This is evident from a high proportion of elderly patients who were not willing to undergo cholecystectomy or to participate in clinical trials. Second, the published randomized studies consisted of small number of patients, and these studies were not sufficiently powered to detect a difference in death related to recurrent biliary events. Third, the Dutch study suggested that quality of life appears unimpaired based on limited SF-36 measurements, even with gallbladders left in situ. Fourth, if a patient chose to adopt a wait-and-see policy, the odds that he/she would remain symptom free and avoid cholecystectomy is more than 50% at 3 years, based on extrapolation of data from the Dutch study. The odds are even better (75% at 5 years) based on the Hong Kong data. Fifth, recurrent bile duct stones often can be treated adequately by repeat ERCP and with minimal morbidities. Sixth, rates of recurrent biliary events in randomized studies were somewhat higher than in cohort studies. The true incidence of recurrent bile duct stones is unknown. We still require a large prospective cohort study with carefully defined outcome events and a sufficiently long follow-up period to identify patients who will develop recurrences. Is Cholecystectomy Safe in the Very Elderly?Laparoscopic cholecystectomy for complicated gallstone disease is difficult. Costi et al summarized 10 series reporting the use of laparoscopic cholecystectomy among patients older than 75 years of age. The overall mortality rate was 13 of 644 (2%) patients. The mortality rate may be the result of a case mix of mostly patients with symptomatic gallstones. The findings emphasize the fact that judicious selection of patients leads to good results. The timing of laparoscopic cholecystectomy after endoscopic sphincterotomy has not been well studied. Early laparoscopic cholecystectomy may be easier before the inflammatory process has progressed to the point of problematic adhesions and scarring. Laparoscopic cholecystectomy for complicated gallstone disease is difficult. Costi et al summarized 10 series reporting the use of laparoscopic cholecystectomy among patients older than 75 years of age. The overall mortality rate was 13 of 644 (2%) patients. The mortality rate may be the result of a case mix of mostly patients with symptomatic gallstones. The findings emphasize the fact that judicious selection of patients leads to good results. The timing of laparoscopic cholecystectomy after endoscopic sphincterotomy has not been well studied. Early laparoscopic cholecystectomy may be easier before the inflammatory process has progressed to the point of problematic adhesions and scarring. Residual or Recurrent Biliary DiseaseThe majority of recurrent biliary events take place within the first year of endoscopic sphincterotomy and clearance of choledocholithiasis. In fact, it can be difficult to distinguish recurrence or residual disease. In the event of bile duct stones, complete stone clearance is difficult to assure even on occlusion cholangiogram, especially in patients with dilated ducts. Magnetic resonance cholangiopancreatography, endosonography, or cholangioscopy may provide useful information. More studies are required.In the Hong Kong study, 10% of patients who underwent surgery near the time of endoscopic sphincterotomy were found to have acute cholecystitis during laparoscopy. If a patient develops cholecystitis shortly after endoscopic sphincterotomy, it could be a co-existing disease that was resolved incompletely. The majority of recurrent biliary events take place within the first year of endoscopic sphincterotomy and clearance of choledocholithiasis. In fact, it can be difficult to distinguish recurrence or residual disease. In the event of bile duct stones, complete stone clearance is difficult to assure even on occlusion cholangiogram, especially in patients with dilated ducts. Magnetic resonance cholangiopancreatography, endosonography, or cholangioscopy may provide useful information. More studies are required. In the Hong Kong study, 10% of patients who underwent surgery near the time of endoscopic sphincterotomy were found to have acute cholecystitis during laparoscopy. If a patient develops cholecystitis shortly after endoscopic sphincterotomy, it could be a co-existing disease that was resolved incompletely. Published GuidelinesAll published guidelines endorse a policy of cholecystectomy for complicated gallstone disease. However, none made specific reference to the need for cholecystectomy after endoscopic sphincterotomy for bile duct stones. It is implicit that endoscopic sphincterotomy is not definitive in patients with both cholelithiasis and choledocholithiasis. The Society of Surgeons of the Alimentary Tract guidelines state that gallstone pancreatitis, choledocholithiasis, and cholangitis require immediate surgical consultation. The guidelines further state that common bile duct stones may be removed either endoscopically or surgically and that, because most common bile duct stones arise from the gallbladder, cholecystectomy also is indicated during surgical exploration of the common bile duct. The American College of Physicians guidelines for the treatment of gallstones published a decade ago recommended that: “Symptomatic patients who opt for expectant management would have to believe that the gains from prophylactic cholecystectomy, in terms of life expectancy, do not warrant intervention. For such patients, the decision between immediate treatment or expectant management may be more a matter of personal choice and convenience.” All published guidelines endorse a policy of cholecystectomy for complicated gallstone disease. However, none made specific reference to the need for cholecystectomy after endoscopic sphincterotomy for bile duct stones. It is implicit that endoscopic sphincterotomy is not definitive in patients with both cholelithiasis and choledocholithiasis. The Society of Surgeons of the Alimentary Tract guidelines state that gallstone pancreatitis, choledocholithiasis, and cholangitis require immediate surgical consultation. The guidelines further state that common bile duct stones may be removed either endoscopically or surgically and that, because most common bile duct stones arise from the gallbladder, cholecystectomy also is indicated during surgical exploration of the common bile duct. The American College of Physicians guidelines for the treatment of gallstones published a decade ago recommended that: “Symptomatic patients who opt for expectant management would have to believe that the gains from prophylactic cholecystectomy, in terms of life expectancy, do not warrant intervention. For such patients, the decision between immediate treatment or expectant management may be more a matter of personal choice and convenience.” RecommendationsA clinician would be tempted to dismiss an elderly debilitated patient after successful endoscopic treatment of their bile duct stones (Figure 2). The algorithm in Figure 1 reflects on experience and the published literature. The existing literature suggests that laparoscopic cholecystectomy would reduce gallstone complications further. It would be prudent first to ask if bile duct stones have migrated from the gallbladder. Soft-pigment stones are formed primarily within the bile duct, whereas cholesterol stones are more likely to have migrated from the gallbladder. Is there concomitant pathology such as a bile duct stricture that was treated adequately? The presence of an intrahepatic ductal stricture would implicate primary cholangitis. Were there gallstones or other features in the gallbladder that warranted intervention? A thick-walled gallbladder, the presence of a polypoid lesion greater than 1 cm in size, or a porcelain gallbladder with thick bile containing calcium would otherwise mandate cholecystectomy. It would be prudent to review the patient’s medical history and to determine if his comorbidities could be optimized further. A surgical consultation certainly should be initiated within the same admission. The patient can be better informed on the probability of recurrences, extrapolating from the published studies thus far and take into account the surgeon’s experience. A decision then can be made in light of the other medical comorbidities and life expectancy of the individual patient (Figure 1). A clinician would be tempted to dismiss an elderly debilitated patient after successful endoscopic treatment of their bile duct stones (Figure 2). The algorithm in Figure 1 reflects on experience and the published literature. The existing literature suggests that laparoscopic cholecystectomy would reduce gallstone complications further. It would be prudent first to ask if bile duct stones have migrated from the gallbladder. Soft-pigment stones are formed primarily within the bile duct, whereas cholesterol stones are more likely to have migrated from the gallbladder. Is there concomitant pathology such as a bile duct stricture that was treated adequately? The presence of an intrahepatic ductal stricture would implicate primary cholangitis. Were there gallstones or other features in the gallbladder that warranted intervention? A thick-walled gallbladder, the presence of a polypoid lesion greater than 1 cm in size, or a porcelain gallbladder with thick bile containing calcium would otherwise mandate cholecystectomy. It would be prudent to review the patient’s medical history and to determine if his comorbidities could be optimized further. A surgical consultation certainly should be initiated within the same admission. The patient can be better informed on the probability of recurrences, extrapolating from the published studies thus far and take into account the surgeon’s experience. A decision then can be made in light of the other medical comorbidities and life expectancy of the individual patient (Figure 1).