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

January 27, 2010
June 26, 2013
April 2010
November 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01057940 on ClinicalTrials.gov Archive Site
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Pilot to Assess DBE as a Rescue Technique for Failed PEJ
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients who have failed conventional DPEJ placement

Patients Who Have Failed Conventional DPEJ Placement
Procedure: DBE PEJ placement
One time procedure with follow-up telephone call.
PEJ placement
Patients who have failed conventional DPEJ placement and would otherwise require surgical intervention.
Intervention: Procedure: DBE PEJ placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01057940
09-008410
No
Louis-Michel Wong Kee Song, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Louis Wong kee song, MD Mayo Clinic
Mayo Clinic
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP