A randomized clinical trial investigating LanreotIde For output reduction in patients with high-output Enterocutaneous fistula or enterostomie

A randomized clinical trial investigating LanreotIde For output reduction in patients with high-output Enterocutaneous fistula or enterostomie - LIFE study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44776

Enrollment

Registered

2013-10-18

Start date

2014-03-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

connection between gasrointesinal tract and the skin whereby losing many fluids and electrolytes high out-put enterocutaneous fistula or high-output enterostomie

Interventions

Patients will be randomized to one of the following two treatment strategies: standard treatment for high output fistula or high-output enterostomy according to our local protocol or standard treatm

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All adult patients with a high-output fistula (> 500ml/day) or high-output enterostomie (500ml/day) or enterostomy (>1500ml/day) for at least 3 consecutive days. * The diagnosis of fistula origin and localization confirmed by CT/fistulography/ enteral contrast MRI.

Exclusion criteria

Exclusion criteria: Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: * Treatment with short-acting somatostatin (or analogues) in the last 2 weeks or with a long-acting somatostatine analogue in the last 2 months. * Patients with high output pancreatic fistula after pancreatitis * Patients with symptomatic gallbladder disease

Design outcomes

Primary

Measure	Time frame
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. Output will be assessed for 8 weeks or until surgery if within 8 weeks; in mL/24 hrs.	—

Secondary

Measure	Time frame
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 output, percent reduction in total fistula or stoma 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 stoma output volume at endpoint compared with output volume at randomisation.	—

Measure

Time frame

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 output, percent reduction in total fistula or stoma 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 stoma output volume at endpoint compared with output volume at randomisation.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)