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


- candidate number6015
- NTR NumberNTR1876
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2009
- Secondary IDs09/146 METC UMC Utrecht
- Public TitleClip-assisted Duodenal Feeding Tube Placement: a Single Blind, Randomized Controlled Trial.
- Scientific TitleClip-assisted Duodenal Feeding Tube Placement: a Single Blind, Randomized Controlled Trial.
- ACRONYMCLIP-study
- hypothesisPost-pyloric feeding is frequently required in both critically ill and non-critically ill patients. Duodenal feeding tubes can be placed blind, under fluoscopy or by endoscopy. Migration rates of duodenal tubes are high. By clip-assisted placement of duodenal feeding tubes we hope to prevent migration and decrease the burden for patients and medical costs.
- Healt Condition(s) or Problem(s) studiedPost pyloric feeding
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2009
- planned closingdate1-aug-2010
- Target number of participants140
- InterventionsPatients will be randomised to undergo clip-assisted endoscopic duodenal feeding tube placement or non clip-assisted endoscopic duodenal feeding tube placement.
- Primary outcomeNumber of repeat endoscopies for tube repositioning due to incorrect placed - and migrated tubes.
- Secondary outcome1. 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.
- TimepointsDaily follow-up untill removal of the tube.
One month after removal of the tube patients will be questioned on their experience of tube feeding. Abdominal X-ray is performed immediatly after tube placement, in case of clinical supicion of migration, and just before removal of the tube.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD M.M.C. Hirdes
- CONTACT for SCIENTIFIC QUERIESMD M.M.C. Hirdes
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht(UMCU), department of Gastroenterology and Hepatology
- PublicationsN/A
- Brief summaryRationale:
Duodenal feeding tubes are frequently required for enteral feeding, but have a high migration rate (10-36%). Few clinical studies evaluated the use of clips in anchoring duodenal feeding tubes (DFT) to the duodenal wall. All studies were performed in small, non-randomised, selected groups of patients. By clip-assisted placement of duodenal feeding tubes we hope to prevent migration and decrease the burden for patients and medical costs.

Objective:
To compare the number of repeat endoscopies for migration rate and incorrect placement of endoscopic clip-assisted duodenal feeding tube (C-DFT) placement with non clip-assisted endoscopic duodenal tube placement (DFT).

Study design:
Single blind randomized controlled trial.

Study population:
139 patients (age ≥ 18 years) undergoing placement of duodenal feeding tube for at least 3 days will be enrolled.

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

Main study parameter:
1. Number of repeat endoscopies for incorrectly placed and migrated nasoentreal feeding tubes.
Others endpoints:
2. Success rate of tube placment;
3. Time of endoscopic porcedure;
4. Dwell time of feeding tube;
5. Costs;
6. Patient's preferences.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Burden: An additional abdominal X- ray is performed to confirm location of duodenal feeding tube before removal in each patient. In case of unexpected MRI investigation, in a patient randomised for clip-assisted duodenal feeding tube placement, the DFT with endoclip has to be removed in advance by manual withdrawal.
Benefit: A decrease can be expected in migration rate, in patients undergoing repeat endoscopic procedures and in cost of medical care.
- Main changes (audit trail)
- RECORD24-jun-2009 - 6-feb-2011


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