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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01525355
Enrollment
34
Registered
2012-02-02
Start date
2010-10-31
Completion date
2016-06-07
Last updated
2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calculi, Stenosis of Bile Duct

Keywords

EUS, ERCP, Intraoperative cholangiogram, Cholecystectomy, Common Bile Duct Stones, Strictures, Stenosis, Duodenum, Dilated Bile duct, Non-filling of the duodenum by contrast

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bile Duct2 yearsStone seen by EUS confirmed by ERCP

Secondary

MeasureTime frameDescription
Lesions2 YearsPresence of obstuctinn lesion seen by EUS
Bile duct2 yearsDiameter of common bile duct and common hepatic duct
Diverticulum2 yearsPresence of periampullary diverticulum seen by endoscopy
ERCP2 yearsNumber of ERCP's that could have been avoided

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026