enterocutaneous fistula, enterocutane fistels, Lanreotide, output reduction, output reductie
Conditions
Interventions
Standard care + Lanreotide 120mg deep subcutaneous injections once every 4 weeks versus standard of care
Sponsors
Academic Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - aged 18 years or older - confirmed diagnosis and localisation of fistula origin (CT/fistulography/enteral contrast MRI) - Clinical decision by treatment team to start medical and nutritional therapy to reduce output - high output fistula (>500ml/day) or high-output enterostomy (>1500ml/day) during 3 consecutive days - at least 4 weeks post-operative after abdominal surgery and received at least 2 weeks ‘standard care’
Exclusion criteria
Exclusion criteria: - recent treatment with short acting somatostatin analogues (>1 week consecutive treatment in past 3 months) - High ouput fistula after pancreatitis or pancreatic surgery - symptomatic gallbladder disease - pregnancy or breastfeeding - known hypersensitivity for Lanreotide, Somatostatin analogues or one of the compounds of the drugs - Patients in whom concomitant administration of Lanreotide and Cyclosporine cannot be avoided -Patients in whom concomitant administration of Lanreotide and Bromocriptine cannot be avoided - Patients taking drugs with a narrow therapeutic window that are mainly metabolized by CYP3A4. - Pancreas fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 fistula output from pre randomisation - no. of days in hospital - changes in needed iv fluid (mL) | — |
Contacts
Public ContactS.L. Gans
AMC, Amsterdam
Outcome results
None listed