Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

Pancreas Disease Clinical Trial

Official title:

Prospective Evaluation of the Clinical Utility of Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620632
• Other study ID #: IRB201600462
• Secondary ID: 511-2011
• Status: Completed
• Start date: December 2011
• Est. completion date: July 2, 2018

Study information

• Verified date: July 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.

Description:

Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

• Altered gastric anatomy

• Scheduled to undergo laparoscopy-assisted ERCP

Exclusion Criteria:

• Any contraindications to performing endoscopy

• Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

• The subject is unable/unwilling to give informed consent

Related Conditions & MeSH terms

• Biliary Disease
• Gallbladder Diseases
• Pancreas Disease
• Pancreatic Diseases

Intervention

Procedure:
• Laparoscopy assisted ERCP
Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.

Locations

Country	Name	City	State
United States	Shands at the University of Florida	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	patients with altered gastric anatomy who need an ERCP		approximately one week