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).
Conditions
Interventions
Trade Name: Somatuline AutoSolution 120 mg
Product Name: Lanreotide autosolution
Product Code: BIM 23014
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Lanreotide
CAS Number
Sponsors
Academic medical center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of treatment with Lanreotide versus current standard of treatment on output reduction in patients with high output enterocutaneous fistulas or enterostomies. ;Secondary Objective: Secondary endpoints are days to full oral or enteral nutrition, change in need of intravenous fluid/TPN per week, time to reach the maximal effect in fistula or enterostomy output, percent reduction in total fistula or enterostomy output from pre randomisation, total number of days in hospital, changes in needed electrolytes (calcium, magnesium, potassium, phosphate, bicarbonate), wound care, quality of life (EQ-5D/qaly’s), analysis of costs, absolute fistula or enterostomy output volume at endpoint compared with output volume at randomisation.;Primary end point(s): The primary endpoint is the number of responders in week 8. Definition of a responder is a decrease in output of >25% at week 8 compared with baseline output at randomisation (Output will be assessed for 8 weeks or until surgery if within 8 weeks; in mL/24 hrs;);Timepoint(s) of evaluation of this end point: the primairy outcome will be measured 8 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • days to full oral or enteral nutrition • change in amount of TPN/week • time to reach the maximal effect in fistula output. • Percent reduction in total output from pre randomisation • no. of days in hospital • changes in needed iv fluid • changes in needed electrolytes • Wound care • Quality of life • Analysis of costs • Absolute output volume at endpoint compared with output volume at randomisation. ;Timepoint(s) of evaluation of this end point: 8 weeks and 16 weeks after randomisation | — |
Countries
Netherlands
Contacts
Public ContactCoordinator
Academic medical center
Outcome results
None listed