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A clinical trial investigating the effect of Lanreotide on the reduction of output in patients with high-ouput enterocutaneous fistula or high-output enterostomy


- candidate number16500
- NTR NumberNTR4437
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-feb-2014
- Secondary IDs2013-003998-10 NL46334.018.13
- Public TitleA clinical trial investigating the effect of Lanreotide on the reduction of output in patients with high-ouput enterocutaneous fistula or high-output enterostomy
- Scientific TitleA randomized clinical trial investigating Lanreotide for output reduction in patients with high-ouput enterocutaneous fistula or high-output enterostomy
- ACRONYMLIFE study
- hypothesisEnterocutaneous fistula are a serious complication with a devastating impact on patients life. High output fistula 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 the conservative management of fistula. This study aims to assess the impact of treatment with Lanreotide on fistula output.
- Healt Condition(s) or Problem(s) studiedEnterocutaneous fistula, Lanreotide, Output reduction, Enterostomy
- Inclusion criteria- aged 18 years or older
- high output fistula during 3 consecutive days (>500ml/day) in the 4th week after registration
- 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
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate1-feb-2016
- Target number of participants40
- InterventionsLanreotide 120mg deep subcutaneous injections once every 4 weeks vs Standard of care
- Primary outcomeThe 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)
- TimepointsFollow up at 5,8,9,13,16 weeks
- Trial web sitewww.darmfalenteam.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. S.L. Gans
- CONTACT for SCIENTIFIC QUERIESDrs. S.L. Gans
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)Changes 24-jul-2015:
Hypothesis NEW:
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.

Inclusion criteria NEW:
- 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 NEW:
- Pancreas fistula

Intervention NEW:
Standard care + Lanreotide 120mg deep subcutaneous injections once every 4 weeks versus standard of care
- RECORD18-feb-2014 - 25-jul-2015


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