Pilot to Assess DBE as a Rescue Technique for Failed PEJ

NCT ID: NCT01057940

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patients Who Have Failed Conventional DPEJ Placement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PEJ placement

Patients who have failed conventional DPEJ placement and would otherwise require surgical intervention.

DBE PEJ placement

Intervention Type PROCEDURE

One time procedure with follow-up telephone call.

Interventions

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DBE PEJ placement

One time procedure with follow-up telephone call.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Louis-Michel Wong Kee Song

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louis Wong kee song, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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09-008410

Identifier Type: -

Identifier Source: org_study_id

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