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

NCT ID: NCT03118973

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-27

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Biliary Obstruction Biliary Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with challenging biliary cannulation randomized to either Goff trans-pancreatic septotomy or double wire technique to facilitate biliary cannulation.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Goff

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

Group Type EXPERIMENTAL

Goff trans-pancreatic septotomy vs. Double wire technique

Intervention Type PROCEDURE

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

Double wire

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

Group Type EXPERIMENTAL

Goff trans-pancreatic septotomy vs. Double wire technique

Intervention Type PROCEDURE

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

Interventions

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Goff trans-pancreatic septotomy vs. Double wire technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Subhas Banerjee

OTHER

Sponsor Role lead

Responsible Party

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Subhas Banerjee

Associate Professor of Medicine, Division of Gastroenterology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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38574

Identifier Type: -

Identifier Source: org_study_id