The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
111
Hôpital Nord
Amiens, France
CHU J. Minjoz
Besançon, France
Hôpital Avicenne
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
Time frame: Fistula drainage volume on 3rd day.
Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula.
Time frame: Day 60
Pancreatic or duodenal and small intestine fistula closing rate within D60
Time frame: Day 60
Number of injections received by each patient
Time frame: End of study
Percentage of fistula recurrence during the follow-up period
Time frame: Duration of follow-up period for each patient is of 1 month
Percentage of mortality in each group
Time frame: End of study
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