Clip-assisted Duodenal Feeding Tube Placement: a Single Blind, Randomized Controlled Trial.
- Conditions
- Post-pyloric feeding, Clip-assisted nasoenteral feeding tube, randomised study, migration
- Registration Number
- NL-OMON28110
- Lead Sponsor
- Prof. P.D.Siersema, MD, PhDDepartment of Gastroenterology and HepatologyUniversity Medical Center UtrechtP.O. Box 85500, 3508 GA UtrechtHeidelberglaan 100, 3584 CX UtrechtTel nr: 088-755 9338
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
1. All adult patients needing a duodenal feeding tube (including triple lumen tubes);
2. Written informed consent provided by patient or representative;
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of repeat endoscopies for tube repositioning due<br>to incorrect placed - and migrated tubes.
- Secondary Outcome Measures
Name Time Method 1. Success rate of tube placement (confirmed by abdominal X-ray);<br /><br>2. Time of endosocpy procedure;<br /><br>3. Dwell time of feeding tube;<br /> <br>4. Costs;<br /> <br>5. Patient's preferences;<br /><br>6. Migration rate to stomach or esophagus.