To assess the impact of treatment with Lanreotide versus current standard of treatment on output reduction in patients with high output enterocutaneous fistula or high-output stoma.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
High output fistulas or high-output enterostomies are associated with a number
of complications such as dehydration, malnutrition, psychological and wound
care problems due to the nature of the condition. 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 in high-output fistulas or high-output
enterostomies. Reduction of fistula or stoma output by 25% could prevent
artificial nutritional support, dehydration and wound care problems and improve
the quality of life. Lowering output could lead to a reduction of admission
time or number of readmissions, and thereby reduce hospital stay and costs of
treatment.
Study objective
To assess the impact of treatment with Lanreotide versus current standard of
treatment on output reduction in patients with high output enterocutaneous
fistula or high-output stoma.
Study design
This is a randomized, non blinded multicenter clinical trial comparing standard
of care with standard of care combined with Lanreotide for adult patients with
a high output small bowel fistula (> 500ml/day) or high-output enterostomie
(>1500ml/day) after gastro-intestinal or abdominal wall surgery. The primary
objective is to compare the proportion of responders to treatment (a responder
is defined as decrease in output > 25% in week 8 compared with baseline
output).
Intervention
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 treatment combined with Lanreotide
autosolution 120 mg deep subcutaneously, once every four weeks.
Study burden and risks
Both treatment regimens are currently used as standard of care in the
Netherlands and the investigational product is used off label for the treatment
of high output enterocutaneous fistula or high-output enterostomies. Possible
benefits of Lanreotide are lower risk of recurrent readmissions, less wound
problems or less dehydration/malnutrition related to high output. Lowering
output could lead to a reduction of admission time or number of readmissions,
and thereby reduce hospital stay. The most commonly expected adverse drug
reactions following treatment with Lanreotide 120 mg are gastrointestinal
disorders (most commonly reported are diarrhoea and abdominal pain, usually
mild or moderate and transient), cholelithiasis (often asymptomatic) and
injection site reactions (pain, nodules and indurations).
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
All adult patients with a high-output fistula (> 500ml/day) or high-output enterostomie (<1500 ml/day) after gastro-intestinal, abdominal wall surgery will be registered from the moment are referred to our multi-disciplinary outpatient treatment team. ;Inclusion criteria for randomization:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Adult patients minimal 4 weeks after abdominal surgery
* Received minimal 2 weeks standard treatment
* High output small bowel fistula (>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
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
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2013-003998-10-NL |
| CCMO | NL46334.018.13 |