Treatment of dumping syndrome with Lanreotide Autogel

Phase 4

Conditions: Dumping syndrome
10018012

Registration Number: NL-OMON31107

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Responses on the dumping provocation tests</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Dumping symptoms, side effects and tolerability as measured by a treatment<br /><br>specific questionnaire (TSQ)<br /><br>-The global severity of symptoms is measured by a Global Disease Severity<br /><br>Score (GDSS)<br /><br>-The severity of other abdominal symptoms including upper abdominal pain, lower<br /><br>abdominal pain, nausea/vomiting, fullness/satiety, bloating, upper abdominal<br /><br>pain, heartburn/regurgitation, lower abdominal pain, diarrhoea, constipation.<br /><br>-Health related quality of life (HRQL)<br /><br>-Global relief score (GR)<br /><br>-Global evaluation of efficacy score (GEES)<br /><br>-Concomittant pain medication<br /><br>-Faecal fat excretion<br /><br>-Body weight<br /><br>-Gallbladder ultrasound</p><br>