Status:
COMPLETED
Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Enterostomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02713776
Start Date
December 13 2016
End Date
January 8 2021
Last Update
December 19 2025
Active Locations (14)
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1
Chu Amiens-Picardie
Amiens, France, 80054
2
Chu Estaing
Clermont-Ferrand, France, 63003
3
Hopital Beaujon
Clichy, France, 92110
4
Chu Albert Michallon
La Tronche, France, 38700