EUS Prior to ERCP in the Positive Setting of Positive Intraoperative Cholangiogram (IOC) During Cholecystectomy

Study Overview
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Brief Summary
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Performing an EUS prior to ERCP in the setting of a positive intraoperative cholangiogram will identify and risk stratify patients for the presence of CBD stones and strictures.

Detailed Description
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During routine cholecystectomy, surgeons will often perform an intraoperative cholangiogram in an effort to define anatomical landmarks and ensure patency and drainage of the common bile duct. This involves injecting a radiopaque contrast medium into the biliary tree during the operation. Occasionally contrast injection onto the common bile duct will reveal an abnormality and are deemed a positive intraoperative cholangiogram (positive IOC). These abnormalities can include the following: single or multiple stones; non-filling of the duodenum by contrast; stenosis or narrowing of the common bile duct (CBD). When discovered these findings are better addressed and treated endoscopically via endoscopic retrograde cholangiopancreatography (ERCP). ERCP's are considered the gold standard for the diagnosis and treatment of positive intraoperative cholangiograms. However, several studies have shown that 40-50% of patients who undergo an ERCP after a positive IOC have a normal cholangiogram. Reasons for this include spontaneous stone passage of the stone, dysmotility of the biliary tree, or poor quality, incomplete, or misinterpretation of the IOC. Therefore ERCP's are being performed when they could be avoided. ERCP performance carries significant complications including pancreatitis (5-10%), bleeding, and perforation. Ideally if a safer test to assess the bile duct could be performed immediately prior to the ERCP to confirm the presence of the positive IOC findings, this would ensure that the ERCP is being performed for therapeutic means thus avoiding unnecessary ERCP's. EUS is often performed prior to ERCP's under the same sedation in our endoscopy unit. From 2005 to 2007, two hundred and twenty seven combined EUS and ERCP procedure were performed.(unpublished internal data). Our experience with combined EUS and ERCP procedures has demonstrated that performing an EUS prior to an ERCP will prolong the total procedure time less than 10 minutes with no significant increase in adverse events. Performance of an EUS prior to ERCP to confirm biliary pathology after a positive IOC has never been studied in a rigorous fashion.

Official Title
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A Prospective Study Evaluation the Role of EUS Prior to ERCP in the Positive Setting of Positive Intraoperative Cholangiogram (IOC) During Cholecystectomy

Conditions
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Calculi, Stenosis of Bile Duct

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be able to review and sign informed consent Cholecystectomy must have been performed within one month of enrollment Positive intraoperative cholangiogram Stone Multiple Stones Stenosis non filling of duodenum Dilated bile duct Exclusion Criteria: Cannot give and sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EUS prior to ERCP<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bile Duct | Stone seen by EUS confirmed by ERCP | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesions | Presence of obstuctinn lesion seen by EUS | 2 Years | 
| Bile duct | Diameter of common bile duct and common hepatic duct | 2 years | 
| Diverticulum | Presence of periampullary diverticulum seen by endoscopy | 2 years | 
| ERCP | Number of ERCP's that could have been avoided | 2 years | 
| ERCP | Complications from ERCP | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS, ERCP, Intraoperative cholangiogram, Cholecystectomy, Common Bile Duct Stones, Strictures, Stenosis, Duodenum, Dilated Bile duct, Non-filling of the duodenum by contrast