No registrations found.
ID
Source
Brief title
Health condition
enterocutaneous fistula, enterocutane fistels, Lanreotide, output reduction, output reductie
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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)
Background summary
In this randomized clinical trial we assess the influence of Lanreotide on the reduction of output in patients with high output enterocutaneous fistula or high-output enterostomy.
Study objective
High-output enterocutaneous fistula (>500ml/day) or high-output enterostomy (>1500 ml/day) are associated with a number of complications such as dehydration, malnutrition psychological and wound care problems. Lanreotide inhibits the exocrine secretion of gastrointestinal fluid and increases the net absorption of water and electrolytes. Because of these properties Lanreotide is believed to be useful in output reduction. This study aims to assess the impact of treatment with Lanreotide on fistula or stoma output.
Study design
Follow up at 5,8,9,13,16 weeks
Intervention
Standard care + Lanreotide 120mg deep subcutaneous injections once every 4 weeks versus standard of care
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
- 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
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL4293 |
| NTR-old | NTR4437 |
| Other | NL46334.018.13 : 2013-003998-10 |