Digestive Fistulae
Conditions
Keywords
Treatment
Brief summary
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
Detailed description
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.
Interventions
DRUGLanreotide microparticles
DRUGPlacebo
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient with pancreatic, duodenal, or small intestine fistula * Patient with simple, externalised fistula * Patient with fistula for which a medical conservative treatment is considered * Patient with: * for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively, * for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days
Exclusion criteria
* Patient expected to require a surgical treatment of the fistula during the study * Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies. * Patient receiving long-term corticotherapy * Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month. * Patient having previously undergone a transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. | Fistula drainage volume on 3rd day. |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Day 60 |
| Pancreatic or duodenal and small intestine fistula closing rate within D60 | Day 60 |
| Number of injections received by each patient | End of study |
| Percentage of fistula recurrence during the follow-up period | Duration of follow-up period for each patient is of 1 month |
| Percentage of mortality in each group | End of study |
Countries
France, Russia
Outcome results
None listed