Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Study Overview
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Brief Summary
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Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography for acute biliary pancreatitis is a controversial issue. There are still many confounding findings offering either early laparoscopic cholecystectomy within 72 hours following endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is known to be an important factor in peritoneal healing and adhesion formation. Measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.

Detailed Description
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Peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion formation. It is expected that endoscopic retrograde cholangiography is a trauma causing adhesions around the hepatobiliary area. Such adhesions may cause some difficulty for consequent gallbladder surgery. For that reason, tissue measurements of factors indicating degree of peritoneal healing and adhesion is helpful for timing of such surgical interventions. Patients are going to be randomized to early and delayed surgery groups. Sampling of peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after endoscopic retrograde cholangiography is performed. Tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are going to be studied by using commercial assays. Peritoneal fibrinolytic activity and surgical outcomes are going to be compared.

Official Title
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Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Conditions
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Cholelithiasis Associated With Common Bile Duct Stones

Intervention / Treatment
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* Other: tissue sampling from peritoneum of the gallbladder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis Exclusion Criteria: contraindication to laparoscopy unsuccessful endoscopic retrograde cholangiography complicated acute biliary pancreatitis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: activity of peritoneal fibrinolysis<br>measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 | Other: tissue sampling from peritoneum of the gallbladder<br>* tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis<br>|
| Active Comparator: surgical outcomes<br>surgical outcomes of laparoscopic cholecystectomy | Other: tissue sampling from peritoneum of the gallbladder<br>* tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography | measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1 | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography | evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholelithiasis, laparoscopic cholecystectomy, endoscopic sphincterotomy, choledocholithiasis