Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

Pancreatobiliary Disease Clinical Trial

Official title:

Prospective Evaluation of Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) With Overtube in Patients With Altered Gastric Anatomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238341
• Other study ID #: Pancreatobiliary disorders
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: October 2, 2015
• Start date: June 2007
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Altered Gastric Anatomy
• Pancreatobiliary Disease

Intervention

Procedure:
• Endoscopic Retrograde Cholangiopancreatography (ERCP)
An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy

Locations

Country	Name	City	State
United States	Shands at UF Endoscoppy Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Papilla or Duct-enterostomy Was Reached		During procedure, up to 3 hours	No
Secondary	Successful Cannulation of the Duct of Intent	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.	During procedure, up to 3 hours	No
Secondary	Successful Endoscopic Therapy		During procedure, up to 3 hours	No
Secondary	Total Procedure Time		During procedure, up to 3 hours	No