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

NCT ID: NCT02713776

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-13
• Study Completion Date: 2021-01-08

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 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.

Conditions

Enterostomy

Keywords

High-Output Enterostomy; Pasireotide; Somatostatin Analogues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pasireotide

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.

Group Type: EXPERIMENTAL

Pasireotide

Intervention Type: DRUG

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

Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.

Interventions

Pasireotide

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.

Intervention Type: DRUG

Placebo

Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.

Intervention Type: DRUG

Other Intervention Names

Pasireotide 0.9 mg (SIGNIFOR®) and Pasireotide 60mg Long Acting Release (LAR); Placebo of pasireotide 0.9 mg by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of pasireotide LAR (Long Acting Release) 60mg on Day 4

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eddy COTTE, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Locations

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

Bordeaux Chu - Hopital Haut-Leveque

Pessac, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Chu Rouen Ch. Nicolle

Rouen, , France

Toulouse - Chu Purpan

Toulouse, , France

Countries

France

References

Beffara B, Hadj-Bouziane F, Hamed SB, Boehler CN, Chelazzi L, Santandrea E, Macaluso E. Dynamic causal interactions between occipital and parietal cortex explain how endogenous spatial attention and stimulus-driven salience jointly shape the distribution of processing priorities in 2D visual space. Neuroimage. 2022 Jul 15;255:119206. doi: 10.1016/j.neuroimage.2022.119206. Epub 2022 Apr 12.

Reference Type: RESULT

PMID: 35427770 (View on PubMed)

Other Identifiers

2014_880

Identifier Type: -

Identifier Source: org_study_id