Clinical trial NCT00729313: Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
Official title: A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Digestive Fistulae
Keywords: Treatment
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
timeFrame: Fistula drainage volume on 3rd day.
Secondary outcomes:
measure: 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.
timeFrame: Day 60
measure: Pancreatic or duodenal and small intestine fistula closing rate within D60
timeFrame: Day 60
measure: Number of injections received by each patient
timeFrame: End of study
measure: Percentage of fistula recurrence during the follow-up period
timeFrame: Duration of follow-up period for each patient is of 1 month
measure: Percentage of mortality in each group
timeFrame: End of study
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Nord
city: Besançon
country: France
facility: CHU J. Minjoz
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: Hôpital A. Michallon
city: Kremlin Bicêtre
country: France
facility: CHU de Bicêtre
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hotel Dieu
city: Marseille
country: France
facility: Hôpital Nord
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Tours
country: France
facility: Hôpital Trousseau
city: Vandoeuvre les Nancy
country: France
facility: Hôpital de Brabois
city: Moscow
country: Russian Federation
facility: Institute of Surgery n.a. A.V. Vishnevsky
city: Moscow
country: Russian Federation
facility: National Research Centre of Surgery
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7. doi: 10.1097/sla.0b013e3181b2489f.