A clinical trial investigating the effect of Lanreotide on reducing fistula output in patients with high output enterocutaneous fistula

Phase 1

• Conditions: All adult patients with a small bowel fistula with an output > 500ml/day or a an enterostomy with an output > 1500ml/day after gastro-intestinal, abdominal wall surgery. Randomization is possible if patients are at least 4 weeks postoperative and had at least 2 weeks of standard care (loperamide, codeine, PPI).; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-003998-10-NL
• Lead Sponsor: Academic medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-18
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adult patients with high output enterocutaneous fistula (>500ml/day) or high output enterostomy (>1500ml/day) existing for at 4 weeks after surgery where the clinical decision has been made by the treating team to reduce output using medical therapy (standard regimen, i.e. PPI, codeine, loperamide, reduction in oral intake) for at least 2 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Recent treatment with short-acting somatostatin (or analogues) for a consecutive period of more than 1 week (within past 3 months)
•Patients with high output pancreatic fistula after pancreatitis
•Patients with symptomatic gallbladder disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified