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CompletedNCT01525355Updated Nov 7, 2017

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

An observational study in Calculi and Stenosis of Bile Duct, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by Wake Forest University Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years to 85 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Calculi
  • Stenosis of Bile Duct

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Keywords

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

Calculi

292 studies on the registry are indexed under Calculi; 38 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 58 observational studies indexed under Calculi.

Browse Calculi studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who have gone an uncomplicated cholesytectomy and determined to have a "positive intraoperative cholangiogram" within one month of presentation to Wake Forest Baptist Health.

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

Exclusion Criteria:

  • Cannot give and sign informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)

Groups and cohorts

  • EUS prior to ERCP
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What researchers measure

Primary outcomes

  1. Bile Duct

    Stone seen by EUS confirmed by ERCP

    Time frame: 2 years

Secondary outcomes

  1. Lesions

    Presence of obstuctinn lesion seen by EUS

    Time frame: 2 Years

  2. Bile duct

    Diameter of common bile duct and common hepatic duct

    Time frame: 2 years

  3. Diverticulum

    Presence of periampullary diverticulum seen by endoscopy

    Time frame: 2 years

  4. ERCP

    Number of ERCP's that could have been avoided

    Time frame: 2 years

  5. ERCP

    Complications from ERCP

    Time frame: 2 years

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Study locations

1 site
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01525355
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Feb 2, 2012
Start date
Oct 2010
Primary completion
Jun 7, 2016
Completion
Jun 7, 2016
Last update
Nov 7, 2017

Study contacts

John A Evans, MD
principal investigator · Wake Forest University Baptist Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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