Clip-assisted Duodenal Feeding Tube Placement: a Single Blind, Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28110

Enrollment

140

Registered

2009-06-24

Start date

2009-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-pyloric feeding, Clip-assisted nasoenteral feeding tube, randomised study, migration

Interventions

Patients will be randomised to undergo clip-assisted endoscopic duodenal feeding tube placement or non clip-assisted endoscopic duodenal feeding tube placement.

Eligibility

Inclusion criteria

Inclusion criteria: 1. All adult patients needing a duodenal feeding tube (including triple lumen tubes); 2. Written informed consent provided by patient or representative; 3. Minimal expected enteral feeding duration of 3 days.

Exclusion criteria

Exclusion criteria: 1. Subjects with a reasonable probability of undergoing a MRI scan (Resolution™ endoclips are not MRI compatible); 2. Women with known pregnancy (because of abdominal X-rays performed in order to confirm location of the DFT).

Design outcomes

Primary

Measure	Time frame
Number of repeat endoscopies for tube repositioning due to incorrect placed - and migrated tubes.	—

Secondary

Measure	Time frame
1. Success rate of tube placement (confirmed by abdominal X-ray); 2. Time of endosocpy procedure; 3. Dwell time of feeding tube; 4. Costs; 5. Patient's preferences; 6. Migration rate to stomach or esophagus.	—

Contacts

Public ContactM.M.C. Hirdes

P.O. Box 85500, 3508 GA Utrecht

m.m.c.hirdes@umcutrecht.nl+31 88 755 1309/ #4596

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)