Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs

NCT03118973 | Completed DMC

• 1 other identifier: 38574
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Obstruction; Biliary Stones

Outcome Measures

Primary Outcomes (1)

• Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation

  Successful biliary cannulation

  Day of procedure

Secondary Outcomes (1)

• Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies

  6 months

Study Arms (2)

Goff

EXPERIMENTAL

For patients in whom biliary cannulation is difficult to achieve, Goff trans-pancreatic septotomy will be performed to facilitate biliary cannulation.

Procedure: Goff trans-pancreatic septotomy vs. Double wire technique

Double wire

EXPERIMENTAL

For patients in whom biliary cannulation is difficult to achieve, double wire technique will be used to facilitate biliary cannulation.

Procedure: Goff trans-pancreatic septotomy vs. Double wire technique

Interventions

Goff trans-pancreatic septotomy vs. Double wire technique PROCEDURE

Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.

Double wire; Goff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Subhas Banerjee: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Gastroenterology

Model Details: Patients with challenging biliary cannulation randomized to either Goff trans-pancreatic septotomy or double wire technique to facilitate biliary cannulation.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 18, 2017
• Study Start: September 27, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)