Clinical trial NCT01525355: EUS Prior to ERCP in the Positive Setting of Positive Intraoperative Cholangiogram (IOC) During Cholecystectomy
Official title: A Prospective Study Evaluation the Role of EUS Prior to ERCP in the "Positive" Setting of Positive Intraoperative Cholangiogram (IOC) During Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Bile Duct
timeFrame: 2 years
Secondary outcomes:
measure: Lesions
timeFrame: 2 Years
measure: Bile duct
timeFrame: 2 years
measure: Diverticulum
timeFrame: 2 years
measure: ERCP
timeFrame: 2 years
measure: ERCP
timeFrame: 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Baptist Health
name: John A Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: