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OpenTrials
Completed

NCT Number: NCT01525355

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

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 From 2005 to 2007, two hundred and twenty seven "combined EUS and ERCP procedure were performed.(unpublished internal data).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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bile Duct

    Time frame: 2 years

    Stone seen by EUS confirmed by ERCP

Secondary outcomes

  1. Lesions

    Time frame: 2 Years

    Presence of obstuctinn lesion seen by EUS

  2. Bile duct

    Time frame: 2 years

    Diameter of common bile duct and common hepatic duct

  3. Diverticulum

    Time frame: 2 years

    Presence of periampullary diverticulum seen by endoscopy

  4. ERCP

    Time frame: 2 years

    Number of ERCP's that could have been avoided

  5. ERCP

    Time frame: 2 years

    Complications from ERCP

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2012
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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