Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment

Inclusion criteria

• Male and Female patients ≥ 18 years old ;
• Patients who underwent an intestinal surgery with enterostomy repair in the three weeks preceding the inclusion ;
• Patients with high-output ileostomy or jejunostomy > 1000 ml/24h ;
• Patients with failure of treatment combining oral fluid restriction and loperamide (up to 8 capsules/24h) +/- codeine syrup (10 mg x 3/24h) during 5 days ;
• Patients who gave its written informed consent to participate to the study ;
• Patients affiliated to a social insurance regime.

Exclusion criteria

• Male and Female patients < 18 years old ;
• Patients who did not give its written informed consent to participate to the study ;
• Patients who received somatostatin analogues during the month before inclusion ;
• Patients with symptomatic cholelithiasis or acute or chronic pancreatitis ;
• Patients with uncontrolled diabetes (with HbA1c (glycated hemoglobin) > 8%) ;
• Patients who are hypothyroid and not on adequate replacement therapy ;
• Patients who have congestive heart failure (NYHA (New York Heart Association) Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, advanced heart block or a history of clinically significant bradycardia or acute myocardial infarction within the 6 months preceding randomization ;
• Patients with history of syncope or family history of idiopathic sudden death ;
• Patients with screening or baseline (predose) : QT interval corrected for heart rate using Fridericia's correction (QTcF) QTcF > 450 msec (male), QTcF > 460 msec (female) (QT interval corrected for heart rate using Fridericia's correction) ;
• Patients with not corrected hypokalaemia and/or hypomagnesaemia ;
• Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with alanine transaminase/aspartate transaminase (ALT/AST) > 2 x Upper Limit of Normal (ULN), serum bilirubin > 2 x ULN ;
• Patients with Child-Pugh C cirrhosis ;
• Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control ;
• Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or activated partial thromboplastin time (APTT) ;
• Patients with known hypersensitivity to somatostatin analogues or any other component of the pasireotide LAR ;
• Patients under guardianship ;
• Patients nonaffiliated to a social insurance regime.