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

Biliary Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118973
• Other study ID #: 38574
• Status: Completed
• Phase: N/A
• Start date: September 27, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Obstruction
• Biliary Stones
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Subhas Banerjee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation	Successful biliary cannulation	Day of procedure
Secondary	Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies	Rates of adverse events associated with the ERCP procedure following intervention to facilitate biliary cannulation.	6 months