Pilot to Assess DBE as a Rescue Technique for Failed PEJ

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis-Michel Wong Kee Song, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01057940
First received: January 27, 2010
Last updated: June 26, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Louis-Michel Wong Kee Song, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01057940     History of Changes
Other Study ID Numbers: 09-008410
Study First Received: January 27, 2010
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014