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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Drug: Lanreotide 30 mg microparticle formulation One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h For non-responders patients lanreotide will be stopped. |
|
| 2 | Placebo Comparator | One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h. Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide microparticles | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. | Fistula drainage volume on 3rd day. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Nord | Amiens | 80054 | France | |||
| CHU J. Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19953707 | Result | 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. |
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|
| 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 |
| Besançon |
| 25031 |
| France |
| Hôpital Avicenne | Bobigny | 93009 | France |
| Hôpital de la Cavale Blanche | Brest | 29609 | France |
| Hôpital Louis Mourier | Colombes | 92700 | France |
| Hôpital Henri Mondor | Créteil | 94000 | France |
| Hôpital A. Michallon | Grenoble | 38043 | France |
| CHU de Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Edouard Herriot | Lyon | 69003 | France |
| Hotel Dieu | Lyon | 69288 | France |
| Hôpital Nord | Marseille | 13915 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Groupe Hospitalier Pitié-Salpêtrière | Paris | 75013 | France |
| Hôpital Pontchaillou | Rennes | 35033 | France |
| Hôpital de Hautepierre | Strasbourg | 67098 | France |
| Hôpital Trousseau | Tours | 37044 | France |
| Hôpital de Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Institute of Surgery n.a. A.V. Vishnevsky | Moscow | 113811 | Russia |
| National Research Centre of Surgery | Moscow | 119992 | Russia |