The aim of the study is to compare the effect jejunal with that of gastric tube feeding on abdominal symptoms.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intensity of abdominal pain
Secondary outcome
Secondary parameters of the study are severity of other abdominal symptoms,
health related quality of life, global releave score, global evaluation of
efficacy score, concentrations of circulating gut hormones.
Background summary
Patients with chronic pancreatitis often suffer from abdominal pain which
aggravates after meal ingestion. Enteral nutrition alleviates this pain in some
patients. The hypothesis is that intrajejunal tube feeding is superior to
intragastric tube feeding.
Study objective
The aim of the study is to compare the effect jejunal with that of gastric
tube feeding on abdominal symptoms.
Study design
Double blind, randomized cross-over design.
Intervention
Intragastric and intrajejunal tube feeding.
Study burden and risks
A feeding tube will be placed by endoscopy once in the stomach and once in the
proximal jejunum. At 4 weeks and at 8 weeks the position of the tube is checked
by fluoroscopy. We measure resting energy expenditure once in the screening
phase by non-invasive indirect calorimetry.
A total amount of 140 mL blood will be drawn at 3 visits over a period of 10
-12 weeks. The patient keeps a diary and fills out questionnaires.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
· Pain is aggravated by meal ingestion, at least 3 times per week in past month
· Pain most likely due to chronic pancreatitis (CP)
· Pain is daily (type B-pain)
· Pain is stable for more than 3 months
· Clinical indication for enteral feeding
· Diagnosis of chronic pancreatitis
· Age > 18 y; < 70 y
· able to read and understand the questionnaires
Exclusion criteria
· Intermittent pain with pain free days (type A pain)
· Exocrine pancreatic insufficiency
· Duodenal or choledochal stenosis
· Narcotic analgesics except tramadol
· Surgery of stomach, pancreas, duodenum or jejunum
· Jejunostomy for enteral feeding
· Instable pain medication
· No abstinence from alcohol in alcoholic CP
· Evidence that abdominal pain may not be related to feeding or may not originate from pancreas
· Other disorders of the upper gastrointestinal tract
· Liver or biliary disorders
. Contra-indication for enteral tube placement
. Pregnancy
Design
Recruitment
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 | NL12398.091.06 |