A clinical trial investigating the effect of Lanreotide on the reduction of output in patients with high-ouput enterocutaneous fistula or high-output enterostomy
Recruiting
- Conditions
- enterocutaneous fistula, enterocutane fistels, Lanreotide, output reduction, output reductie
- Registration Number
- NL-OMON25162
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
aged 18 years or older
- confirmed diagnosis and localisation of fistula origin (CT/fistulography/enteral contrast MRI)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of responders in week 8. Definition of a responder is a<br>decrease in output of ≥25% at week 8 compared with baseline output at randomisation.
- Secondary Outcome Measures
Name Time Method - days to full oral or enteral nutrition<br /><br>- change in amount of TPN/week<br /><br>-time to reach the maximal effect in fistula output.<br /><br>- Percent reduction in total fistula output from pre randomisation<br /><br>- no. of days in hospital<br /><br>- changes in needed iv fluid (mL)<br />