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

Trial ID or NCT#

NCT03118973

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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
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Investigator(s)

Subhas Banerjee
Subhas Banerjee
Gastroenterologist, Therapeutic endoscopy specialist, Biliary specialist, Endoscopic ultrasound specialist
Professor of Medicine (Gastroenterology and Hepatology)

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Contact

Subhas Banerjee, MD

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View on ClinicalTrials.gov