|- candidate number||6015|
|- NTR Number||NTR1876|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-jun-2009|
|- Secondary IDs||09/146 METC UMC Utrecht|
|- Public Title||Clip-assisted Duodenal Feeding Tube Placement: a Single Blind, Randomized Controlled Trial.|
|- Scientific Title||Clip-assisted Duodenal Feeding Tube Placement: a Single Blind, Randomized Controlled Trial.|
|- hypothesis||Post-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) studied||Post pyloric feeding|
|- 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||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).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2009|
|- planned closingdate||1-aug-2010|
|- Target number of participants||140|
|- Interventions||Patients will be randomised to undergo clip-assisted endoscopic duodenal feeding tube placement or non clip-assisted endoscopic duodenal feeding tube placement. |
|- Primary outcome||Number of repeat endoscopies for tube repositioning due
to incorrect placed - and migrated tubes.|
|- Secondary outcome||1. Success rate of tube placement (confirmed by abdominal X-ray);|
2. Time of endosocpy procedure;
3. Dwell time of feeding tube;
5. Patient's preferences;
6. Migration rate to stomach or esophagus.
|- Timepoints||Daily 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 site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD M.M.C. Hirdes|
|- CONTACT for SCIENTIFIC QUERIES||MD M.M.C. Hirdes|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Department of Gastroenterology and Hepatology|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht(UMCU), department of Gastroenterology and Hepatology |
|- Brief summary||Rationale: |
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.
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).
Single blind randomized controlled trial.
139 patients (age ≥ 18 years) undergoing placement of duodenal feeding tube for at least 3 days will be enrolled.
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.
2. Success rate of tube placment;
3. Time of endoscopic porcedure;
4. Dwell time of feeding tube;
6. Patient's preferences.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
A decrease can be expected in migration rate, in patients undergoing repeat endoscopic procedures and in cost of medical care.
|- Main changes (audit trail)|
|- RECORD||24-jun-2009 - 6-feb-2011|