Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
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.