Clinical trial NCT03118973: Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
Official title: Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Obstruction
Biliary Stones
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with challenging biliary cannulation randomized to either Goff trans-pancreatic septotomy or double wire technique to facilitate biliary cannulation.
Primary purpose: TREATMENT

Brief summary: Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic septotomy vs. double wire technique for achieving biliary access in patients who fail initial cannulation at ERCP.

Detailed description: Selective placement of a guidewire into the bile duct (biliary cannulation) during endoscopic retrograde cholangiopancreatography (ERCP) is necessary for performing therapeutic biliary procedures. The success rate for biliary cannulation by experienced endoscopists during ERCP is approximately 85% with standard cannulation techniques. Inadvertent placement of the guidewire into the pancreatic duct rather than the bile duct often occurs when attempting selective biliary cannulation in technically challenging cases. When this occurs repeatedly, other approaches may be used to facilitate selective biliary cannulation, but there are few prospective studies evaluating the efficacy and safety of these approaches. Here the investigators evaluate two approaches for technically challenging biliary cannulation: one involving maintenance of a wire in the pancreatic duct, followed by repeat attempt at biliary cannulation (double wire technique) and one involving a small incision in the septum adjacent to the pancreas followed by repeat attempt at biliary cannulation (transpancreatic septotomy). This study is a prospective randomized trial comparing the rate of cannulation success, procedure duration and complications following these two approaches.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and older
2. Patient has a clinical indication for ERCP
3. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age \<18
2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
3. Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
4. Prior sphincterotomy or balloon dilation of ampulla
5. Thrombocytopenia, coagulopathy, or indication for ongoing anti-coagulation therapy
6. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit

Primary outcomes:
measure: Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation
timeFrame: Day of procedure
Secondary outcomes:
measure: Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References: