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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopy first | Active Comparator | 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. |
|
| Cholecystectomy first | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic ultrasound | Procedure | Evaluation of bile ducts with endoscope with special ultrasonographic function |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University Hospital Santaros Klinikos | Recruiting | Vilnius | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538700 | Derived | Aleknaite A, Simutis G, Stanaitis J, Jucaitis T, Drungilas M, Valantinas J, Strupas K. Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 4;10(2):e18837. doi: 10.2196/18837. |
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D042882 | Gallstones |
| D002769 | Cholelithiasis |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
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| intraoperative cholangiography | Procedure | evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy |
|
| ERCP | Procedure | evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum |
|
|
| Ultrasound endoscope | Device | Endoscope with built-in ultrasound function |
|
|
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 |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D013505 | Digestive System Surgical Procedures |