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Pilot to Assess DBE as a Rescue Technique for Failed PEJ

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057940
First Posted: January 28, 2010
Last Update Posted: June 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louis-Michel Wong Kee Song, Mayo Clinic
  Purpose
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.

Condition Intervention
Patients Who Have Failed Conventional DPEJ Placement Procedure: DBE PEJ placement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Assess the Feasibility of Double Balloon Enteroscopy as a Rescue Technique for Failed Direct Percutaneous Endoscopic Jejunostomy Tube Placement

Further study details as provided by Louis-Michel Wong Kee Song, Mayo Clinic:

Enrollment: 20
Study Start Date: April 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PEJ placement
Patients who have failed conventional DPEJ placement and would otherwise require surgical intervention.
Procedure: DBE PEJ placement
One time procedure with follow-up telephone call.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have failed conventional DPEJ placement
Criteria

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:

  1. Age > 18 years old
  2. Appropriate indication for DPEJ tube placement and Nutrition consult approval
  3. Absence of bleeding disorder
  4. Platelet count > 50,000 and INR < 1.5
  5. Ability to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057940


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Louis Wong kee song, MD Mayo Clinic
  More Information

Responsible Party: Louis-Michel Wong Kee Song, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01057940     History of Changes
Other Study ID Numbers: 09-008410
First Submitted: January 27, 2010
First Posted: January 28, 2010
Last Update Posted: June 28, 2013
Last Verified: June 2013