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CompletedNCT01057940Updated Jun 28, 2013

Pilot to Assess DBE as a Rescue Technique for Failed PEJ

An observational study in Patients Who Have Failed Conventional DPEJ Placement, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-28.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Patients Who Have Failed Conventional DPEJ Placement
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have failed conventional DPEJ placement

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • PEJ placement

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

    Procedure: DBE PEJ placement

Interventions

  • ProcedureDBE PEJ placement

    One time procedure with follow-up telephone call.

06

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01057940
Lead sponsor
Mayo Clinic
Responsible party
Louis-Michel Wong Kee Song (MD, Mayo Clinic) — Principal investigator
First posted
Jan 28, 2010
Start date
Apr 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jun 28, 2013

Study contacts

Louis Wong kee song, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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