To compare migration rate to the stomach or esophagus of clip-assisted endoscopic duodenal feeding tube placement with non clip-assisted endoscopic duodenal tube placement.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal stenosis and obstruction
Synonym
Health condition
gastroparese, ernstige reflux, hoog aspiratierisico, proximale enterale fistel, pancreatitis etc
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Migration rate of duodenal feeding tube to the stomach or esophagus
- Failure rate of placement of a duodenual feeding (not in the duodenum,
documented on an abdominal X-ray within three hours of the endoscopic
procedure)
Secondary outcome
1.Succes rate of duodenal feeding tube placement
2. Dwell time of duodenal feeding tube
3. Costs
Background summary
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.
Study objective
To compare migration rate to the stomach or esophagus of clip-assisted
endoscopic duodenal feeding tube placement with non clip-assisted endoscopic
duodenal tube placement.
Study design
Single blind randomized controlled trial
Intervention
Patients will be randomised to undergo clip-assisted endoscopic duodenal
feeding tube placement (n=72) or *standard* endoscopic duodenal feeding tube
placement (n=72)
Thus, the intervention will be the fixation of a duodenal feeding tube by
'clipping' it to the duodenal wall.
Study burden and risks
Burden: One abdominal X-rays is performed to confirm location of duodenal
feeding tube in each patient before removal of the duodenal tube. In case of
unexpected MRI investigation, in a patient randomised for clip-assisted
duodenal feeding tube placement, the duodenal feeding tube (with endoclip
attached) has to be removed in advance ( by manually withdrawal of duodenal
feeding tube, just like in non clip-assisted feeding tube removal). Thirty days
after tube feeding, subject will be contacted by phone to answer questions on
their experience of tube feeding. This accounts only for subjects admitted to a
nursing department, not for subjects admitted to the ICU.
Benefit: We expect that by participating in the study, the risk for tube
migration may decrease. However this benefit is not garantueed. This will
result in a decrease of symptoms related to migrated feeding tubes and a
decrease in repeat upper endoscopies to replace the duodenal feeding tube.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
-Subjects (18 years and older) referred for endoscopic duodenal tube placement
-Expected duration of feeding tube in situ at least 3 days
-Written informed consent
Exclusion criteria
-Subjects with a reasonable probalilty of undergoing a MRI investigation
-Known pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27706.041.09 |