Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

Completed

• Conditions: Altered Gastric Anatomy; Pancreatobiliary Disease
• Interventions: Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

• Registration Number: NCT01238341
• Lead Sponsor: University of Florida

Brief Summary

In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2015-09-02
• Results First Submitted QC: 2015-09-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-02
• Results First Posted: 2015-10-05
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Subject is 18 years or older
2. Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
3. Subject has altered gastric anatomy
4. Subject must be able to give informed consent.

Exclusion Criteria

1. Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
2. The subject is unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatobiliary disease	Endoscopic Retrograde Cholangiopancreatography (ERCP)	Patients who have altered gastric anatomy who need an ERCP with an overtube for evaluation of pancreatobiliary disease.

Primary Outcome Measures

Name	Time	Method
Papilla or Duct-enterostomy Was Reached	During procedure, up to 3 hours

Secondary Outcome Measures

Name	Time	Method
Successful Cannulation of the Duct of Intent	During procedure, up to 3 hours	Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.
Successful Endoscopic Therapy	During procedure, up to 3 hours
Total Procedure Time	During procedure, up to 3 hours

Trial Locations

Locations (1)

Shands at UF Endoscoppy Center; 🇺🇸 Gainesville, Florida, United States