Pilot to Assess DBE as a Rescue Technique for Failed PEJ
June 26, 2013 updated by: Louis-Michel Wong Kee Song, Mayo Clinic
A Pilot Study to Assess the Feasibility of Double Balloon Enteroscopy as a Rescue Technique for Failed Direct Percutaneous Endoscopic Jejunostomy Tube Placement
Is DBE(double balloon enteroscopy)-assisted DPEJ(direct percutaneous endoscopic jejunostomy) a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
DBE-assisted DPEJ is a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have failed conventional DPEJ placement
Description
Patients:
Patients who have failed conventional DPEJ tube placement will be offered participation in the study. DBE-assisted DPEJ will be performed on a subsequent day following failed DPEJ. Patients who do not wish to undergo an attempt at DBE-assisted DPEJ will follow-up with their primary caregiver for alternative means of feeding tube placement (e.g., surgical jejunostomy).
Inclusion criteria:
- Age > 18 years old
- Appropriate indication for DPEJ tube placement and Nutrition consult approval
- Absence of bleeding disorder
- Platelet count > 50,000 and INR < 1.5
- Ability to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PEJ placement
Patients who have failed conventional DPEJ placement and would otherwise require surgical intervention.
|
One time procedure with follow-up telephone call.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Louis Wong kee song, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (ACTUAL)
November 1, 2011
Study Completion (ACTUAL)
November 1, 2011
Study Registration Dates
First Submitted
January 27, 2010
First Submitted That Met QC Criteria
January 27, 2010
First Posted (ESTIMATE)
January 28, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
June 28, 2013
Last Update Submitted That Met QC Criteria
June 26, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 09-008410
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.