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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Wake Forest Baptist Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jerry Evans, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01525355
First received: January 30, 2012
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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 Phase
Calculi
Stenosis of Bile Duct
Phase 0

Study Type: Observational
Study Design: 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

Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Bile Duct [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Stone seen by EUS confirmed by ERCP


Secondary Outcome Measures:
  • Lesions [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Presence of obstuctinn lesion seen by EUS

  • Bile duct [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Diameter of common bile duct and common hepatic duct

  • Diverticulum [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Presence of periampullary diverticulum seen by endoscopy

  • ERCP [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Number of ERCP's that could have been avoided

  • ERCP [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Complications from ERCP


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
EUS prior to ERCP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525355

Contacts
Contact: Robin N Pope 336-713-7336 rpope@wakehealth.edu
Contact: John A Evans, MD 336-716-1252 joevans@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: John A Evans, MD    336-716-1252    joevans@wakehealth.edu   
Principal Investigator: John A Evans, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: John A Evans, MD Wake Forest University Baptist Health
  More Information

No publications provided

Responsible Party: Jerry Evans, Principal Investigator, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01525355     History of Changes
Other Study ID Numbers: IRB00013737
Study First Received: January 30, 2012
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
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
Constriction, Pathologic
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 18, 2014