To determine the efficacy and tolerability of L-Autogel in patients with early or late dumping syndrome after gastric surgery.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Responses on the dumping provocation tests
Secondary outcome
-Dumping symptoms, side effects and tolerability as measured by a treatment
specific questionnaire (TSQ)
-The global severity of symptoms is measured by a Global Disease Severity
Score (GDSS)
-The severity of other abdominal symptoms including upper abdominal pain, lower
abdominal pain, nausea/vomiting, fullness/satiety, bloating, upper abdominal
pain, heartburn/regurgitation, lower abdominal pain, diarrhoea, constipation.
-Health related quality of life (HRQL)
-Global relief score (GR)
-Global evaluation of efficacy score (GEES)
-Concomittant pain medication
-Faecal fat excretion
-Body weight
-Gallbladder ultrasound
Background summary
The dumping sydrome is a serious complication in 10-20% of patients after
gastric surgery. These symptoms occur during, immediately or 1 or 3 hours after
meal ingestion and consists of both gastrointestinal and cardiovascular
components.
Somatostatine analogues are effective in controllling early and late dumping
symptoms. Lanreotide is a new somatostatin analogue and is well tolerated with
fewer local side effects and technical problems with injection when compared to
octreotide LAR.
Study objective
To determine the efficacy and tolerability of L-Autogel in patients with early
or late dumping syndrome after gastric surgery.
Study design
Prospective open label switch study
Study burden and risks
Patients will be asked to discontinue the Sandostatine they used for dumping
symptoms for six weeks. Thereafter they can develop dumping symptoms, to
protect for symptoms patients are allowed to use short acting octreotide 3 days
before V2.
L-Autogel is tolerated with fewer local side effects and technical problems
with injections
Geert Grooteplein- zuid 10
6525 GA Nijmegen
Nederland
Geert Grooteplein- zuid 10
6525 GA Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Dumping provocation test positive
Dumping symptoms devised by Sigstad
Patients with late dumping are selected by postprandial hypoglycaemie plasma glucose <3.0 after 60 min after ingestion of 50 g glucose/m2 body surface and hypoglycaemic symptoms at least 60 min after the oral glucose load.
Patients who have long term octreotide LAR therapy
Age 18 years or older
Informed consent
Exclusion criteria
Patients with disorders of endocrine system
Patients with severe kidney , liver, cardiovascular disease.
Patients who are pregnant or giving breast feeding
Patinets with recent gastrointestinal surgery or other gastrointestinal diseases
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 |
|---|---|
| EudraCT | EUCTR2007-001078-94-NL |
| CCMO | NL16803.091.07 |