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