Clinical Trial: Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

Brief Summary:

The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to angiodysplasia.

No randomized studies are available. The main objective of this study multicenter, prospective, randomized, was to assess the transfusion requirements in patients with recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin, Pasireotide, versus placebo.

Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic treatment failure, with a need transfusion at least 6 red blood cells during the 6 months prior to inclusion could be randomized to receive monthly intramuscular injection of Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an additional 6 months after stopping treatment. A test monthly clinical and laboratory was performed during the six months of treatment then quarterly during the six months of surveillance.

Detailed Summary:

The angiodysplasias are abnormal communications between dilated capillaries and veins. Their presence in the digestive tract is probably due to venous obstruction associated with smooth muscle contractions. These vascular malformations are not a particularly significant cause of bleeding in elderly patients. The angiodysplasias are responsible for about 1% of upper gastrointestinal bleeding and up to 6% of the lower bleeding. However in case of gastrointestinal bleeding obscures the presence of angiodysplasia was found in 23% of cases through an exploration of the small intestine endoscopic video capsule enteroscopy or double balloon. Some conditions promote the development of angiodysplasias such as kidney failure with a prevalence of 13% in case of bleeding or cirrhosis. The responsibility of aortic stenosis is debated and could be a chance association. On the other hand, are more symptomatic bleeding in case of bleeding disorders, in particular von Willebrand disease.

The first line treatment is based on the destruction of endoscopic lesions by laser, or argon plasma coagulation electrocoagulation. However, these lesions may be inaccessible to endoscopic treatment, when they are too numerous or if patients with severe comorbidities, indicating against invasive endoscopic treatments. Iterative transfusions remain the only possible treatment for a significant proportion of patient which induces frequent hospitalizations, complications related to transfusions and a significant cost.

Hormonal treatments have been tried without success to prevent rebleeding. Anti-angiogenic as thalidomide have been tested in phase II trials in low number of the patients.

Somatostatin is a cyclic peptide secreted by D cells in the gastric and intestinal mucosa, by the cells of the islets of La
Sponsor: Robert Benamouzig

Current Primary Outcome: number of red blood cells transfused [ Time Frame: at 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Avicenne

Dates:
Date Received: December 3, 2015
Date Started: March 2012
Date Completion:
Last Updated: December 4, 2015
Last Verified: December 2015