PREVENTION OF POSTOPERATIVE PANCREATIC FISTULA BY SOMATOSTATIN (PREFIPS) - PREFIPS

Phase 1

• Conditions: Patients candidate for pancreatic surgery (pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy).; MedDRA version: 19.0Level: PTClassification code 10049192Term: Pancreatic fistulaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001673-32-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-20
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

o Men or women aged 18 years or greater
o Signed informed consent
o Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 654
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

o Patient with neoadjuvant chemo and/or radiation therapy
o Pregnancy
o Breastfeeding
o Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
o Patients with abnormal coagulation (INR>1.5) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated thromboplastin time)
o Patients with WBC <3 X 109/L; PLT <100 X 109/L
o Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
o Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion
o Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
o Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
o Patients treated by ciclosporine
o Patient without health insurance or social security
o Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified