Digestive Fistulae Clinical Trial
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
| Verified date | March 2019 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
| Status | Completed |
| Enrollment | 111 |
| Est. completion date | April 2005 |
| Est. primary completion date | April 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Nord | Amiens | |
| France | CHU J. Minjoz | Besançon | |
| France | Hôpital Avicenne | Bobigny | |
| France | Hôpital de la Cavale Blanche | Brest | |
| France | Hôpital Louis Mourier | Colombes | |
| France | Hôpital Henri Mondor | Créteil | |
| France | Hôpital A. Michallon | Grenoble | |
| France | CHU de Bicêtre | Kremlin Bicêtre | |
| France | Hôpital Edouard Herriot | Lyon | |
| France | Hotel Dieu | Lyon | |
| France | Hôpital Nord | Marseille | |
| France | Groupe Hospitalier Pitié-Salpêtrière | Paris | |
| France | Hôpital Lariboisière | Paris | |
| France | Hôpital Pontchaillou | Rennes | |
| France | Hôpital de Hautepierre | Strasbourg | |
| France | Hôpital Trousseau | Tours | |
| France | Hôpital de Brabois | Vandoeuvre les Nancy | |
| Russian Federation | Institute of Surgery n.a. A.V. Vishnevsky | Moscow | |
| Russian Federation | National Research Centre of Surgery | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
France, Russian Federation,
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 fistu — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. | Fistula drainage volume on 3rd day. | ||
| Secondary | 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 | ||
| Secondary | Pancreatic or duodenal and small intestine fistula closing rate within D60 | Day 60 | ||
| Secondary | Number of injections received by each patient | End of study | ||
| Secondary | Percentage of fistula recurrence during the follow-up period | Duration of follow-up period for each patient is of 1 month | ||
| Secondary | Percentage of mortality in each group | End of study |