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

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ClinicalTrials.gov Identifier: NCT01525355
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Calculi Stenosis of Bile Duct

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 From 2005 to 2007, two hundred and twenty seven "combined EUS and ERCP procedure were performed.(unpublished internal data).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


Study Design

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Evaluation the Role of EUS Prior to ERCP in the "Positive" Setting of Positive Intraoperative Cholangiogram (IOC) During Cholecystectomy
Actual Study Start Date : October 2010
Primary Completion Date : June 7, 2016
Study Completion Date : June 7, 2016
Groups and Cohorts

Group/Cohort
EUS prior to ERCP


Outcome Measures

Primary Outcome Measures :
  1. Bile Duct [ Time Frame: 2 years ]
    Stone seen by EUS confirmed by ERCP


Secondary Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525355


Locations
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: John A Evans, MD Wake Forest University Baptist Health
More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01525355     History of Changes
Other Study ID Numbers: IRB00013737
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: April 2017

Keywords provided by Wake Forest University Health Sciences:
EUS
ERCP
Intraoperative cholangiogram
Cholecystectomy
Common Bile Duct Stones
Strictures
Stenosis
Duodenum
Dilated Bile duct
Non-filling of the duodenum by contrast

Additional relevant MeSH terms:
Calculi
Pathological Conditions, Anatomical