During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure. This risk implies parenteral correction which may extend hospital stay and delay home return. Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not routinely used for the treatment of patients with high-output enterostomy and their efficacy in the indication (off-label) was only tested in small case series. Pasireotide (SOM230, SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual medical treatment associated with an oral fluid restriction has never been demonstrated before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled trial evaluating its impact on reduction of the effluent volume.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
Pasireotide 0.9 mg by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of pasireotide Long Acting Release (LAR) 60mg on Day 4 morning.
Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.
Chu Amiens-Picardie
Amiens, France
Chu Estaing
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
Chu Albert Michallon
La Tronche, France
Hôpital Claude HURIEZ - CHRU Lille
Lille, France
Centre Leon Berard
Lyon, France
Chu Marseille - Hopital Nord
Marseille, France
Institut Regional Du Cancer Val D'Aurelle
Montpellier, France
Chu Caremeau
Nîmes, France
Hopital Saint Antoine
Paris, France
...and 4 more locations
Compare the efficacy of pasireotide versus placebo in reduction of high-output
Decrease of enterostomy output (ml/24H)within the 72 hours after first injection of treatment
Time frame: Evaluated 72 hours after first injection of treatment
Estimate the success rate of pasireotide and placebo
Number of normal renal function patients in both arms with an enterostomy output than 800 millimeters (mL) /24h within a week after first injection of treatment allowing discontinuation of intravenous perfusion.
Time frame: 1 week after first injection of treatment
Compare the decrease in the length of hospitalization with pasireotide versus placebo
Duration of hospitalization in days in both arms
Time frame: 1 month after the end of treatment
Compare the incidence of premature closure of stoma due to high-output with pasireotide versus placebo
Rate of premature closure of stoma due to high-output (before 2 months after creation) in both arms
Time frame: 2 months after enterostomy creation
Evaluate the economic impact of pasireotide in this indication
Costs of taking care of patients from French Public Health Insurance perspective in both arms
Time frame: 2 months from the inclusion of the patient in the study
Incidence of treatment - Emergent Adverse Events
Nature, number and grade of adverse events observed throughout the study
Time frame: during treatment (4 days), one week, two weeks, three weeks and one month after treatment
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