Overview

Prevention of Postoperative Pancreatic Fistula by Somatostatin

Status:
Completed
Trial end date:
2021-02-09
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Octreotide
Somatostatin
Criteria
Inclusion Criteria:

- Men or women aged 18 years or greater

- Signed informed consent

- Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without
splenectomy

Exclusion Criteria:

- Patient with radiation therapy

- Patient with neoadjuvant chemotherapy within 4 weeks before surgery

- Pregnancy

- Breastfeeding

- 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

- Patients who have participated in any clinical investigation with an investigational
drug within 1 month prior to inclusion

- Known hypersensitivity to somatostatin or somatostatin analogues or any component of
the somatostatin or octreotide long-acting release (LAR) or s.c. formulations

- Patient previously treated with somatostatin or somatostatin analogues or any
component of the somatostatin or octreotide LAR or s.c. formulations

- Patients treated by ciclosporin

- Patient without health insurance or social security

- 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