Endoscopy First or Laparoscopic Cholecystectomy First for Patients With Intermediate Risk of Choledocholithiasis

Study Overview
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Brief Summary
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The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated. Endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ERCP) on demand are performed before laparoscopic cholecystectomy for one arm. Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ERCP on demand are administered in another arm.

Detailed Description
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Use of ERCP as a diagnostic tool should be minimized as it carries considerable risk (5 to 10%) of post-procedural complications. It is noticed that adverse events occur more often to patients with low risk of choledocholithiasis. Therefore the best possible patient selection for ERCP procedure is needed. At the Centre of Abdominal Surgery of Vilnius University Hospital Santaros klinikos an original prognostic index (Vilnius University Hospital index (VUHI)) is used for evaluation of risk of choledocholithiasis. It is calculated by formula VUHI = A/30 + 0.4×B, where A - total bilirubin concentration (µmol/l), B - common bile duct (CBD) diameter measured by ultrasound exam. A retrospective study evaluated its accuracy and determined threshold values for low, intermediate and high risk groups. The intermediate risk group (risk for choledocholithiasis 25-75%) would benefit from additional examination before ERCP. Endoscopic ultrasound (EUS) and intraoperative cholangiography are less invasive procedures with high accuracy identifying common bile duct stones. Main hypothesis of the trial is that intraoperative cholangiography with ERCP on demand can shorten the duration and costs of treatment and avoid diagnostic ERCPs.

Official Title
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Comparison of Two Management Strategies, Endoscopy First and Laparoscopic Cholecystectomy First, for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis

Conditions
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Choledocholithiasis

Intervention / Treatment
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* Procedure: endoscopic ultrasound
* Procedure: intraoperative cholangiography
* Procedure: ERCP
* Device: Ultrasound endoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with cholecystolithiasis when laparoscopic cholecystectomy is indicated intermediate risk for choledocholithiasis (VUHI 2,6 - 6,9 and one of the predictors: dilated common bile duct, elevated total bilirubin or suspected stone in CBD on ultrasound) Exclusion Criteria: pregnancy; acute cholangitis; biliary pancreatitis; acute cholecystitis, degree II-III by Tokyo guidelines 2013; anastomosis in upper gastrointestinal tract; other known cholestatic hepatopancreatobiliary disease; known or suspected hepatitis of another origin (viral, toxic, etc.); contraindications for general anaesthesia or surgery; IV-VI class of American Society of Anesthesiologists physical status classification; morbid obesity (body mass index > 40); patient's refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopy first<br>Endoscopic ultrasound is used to evaluate bile ducts. If stones in extrahepatic bile ducts are seen ERCP and stone evacuation is performed during the same anaesthesia. Laparoscopic cholecystectomy is performed after endoscopic procedures in two days. | Procedure: endoscopic ultrasound<br>* Evaluation of bile ducts with endoscope with special ultrasonographic function<br>Procedure: ERCP<br>* evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum<br>* Other names: endoscopic retrograde cholangiopancreatography;Device: Ultrasound endoscope<br>* Endoscope with built-in ultrasound function<br>* Other names: Endosonoscope;|
| Active Comparator: Cholecystectomy first<br>Laparoscopic cholecystectomy with intraoperative cholangiography is performed. If stones are found postoperative ERCP with stone evacuation is applied (during cholecystectomy if common bile duct is completely blocked or as soon as possible). | Procedure: intraoperative cholangiography<br>* evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy<br>Procedure: ERCP<br>* evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum<br>* Other names: endoscopic retrograde cholangiopancreatography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment | duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days | up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of different management strategies | Proportion of correctly diagnosed (true positive and true negative) cases in all sample | 6 to 7 months | 
| Technical success of interventions (IOC, EUS, ERCP) | For intraoperative cholangiography: successful cannulation and contrast media injection into CBD. For endoscopic sonoscopy: successful visualisation of CBD. For ERCP: successful cannulation and contrast media injection into CBD. | up to one month | 
| Adverse events of interventions | Bleeding, acute pancreatitis, perforation, allergic reactions | up to one month | 
| Costs of treatment | charges of diagnostic procedures, invasive procedures, surgery, antibacterial treatment if needed and hospital charges | up to one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choledocholithiasis, endoscopic ultrasound, ERCP, intraoperative cholangiography, common bile duct stone, endoscopic retrograde cholangiopancreatography, gallstone disease, cholelithiasis, bile duct obstruction, laparoscopic cholecystectomy