Prevention of Postoperative Pancreatic Fistula by Somatostatin (PREFIPS)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Pancreatic Surgery

Treatments

Drug: Octreotide

Drug: Somatostatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03000946

P150915

2016-001673-32 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula

Full description

Prevention of pancreatic fistula remains a major challenge for surgeons, and various technical and pharmacological intervention have been investigated, with conflicting results.

Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection.

In view of recent result, the investigators can hypothesize that higher affinity for somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better pancreatic fistula prevention.

Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will be associated with a improved pancreatic fistula prevention compared to octreotide.

Enrollment

655 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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