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

Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525355
• Other study ID #: IRB00013737
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: November 3, 2017
• Start date: October 2010
• Est. completion date: June 7, 2016

Study information

• Verified date: April 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 7, 2016
• Est. primary completion date: June 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Stenosis of Bile Duct

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile Duct	Stone seen by EUS confirmed by ERCP	2 years
Secondary	Lesions	Presence of obstuctinn lesion seen by EUS	2 Years
Secondary	Bile duct	Diameter of common bile duct and common hepatic duct	2 years
Secondary	Diverticulum	Presence of periampullary diverticulum seen by endoscopy	2 years
Secondary	ERCP	Number of ERCP's that could have been avoided	2 years
Secondary	ERCP	Complications from ERCP	2 years