Clinical trial NCT03000946: Prevention of Postoperative Pancreatic Fistula by Somatostatin
Official title: Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Surgery
Keywords: Pancreatectomy
Somatostatin analogue
Octreotide
Pancreatic fistula
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 655
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
timeFrame: 90 days
Secondary outcomes:
measure: ≥grade 3 pancreatic complication rates (fistula, leak, and abscess)
timeFrame: 60 days
measure: Overall pancreatic fistula rate (grade A,B and C)
timeFrame: 90 days
measure: Overall pancreatic fistula rate (grade B and C)
timeFrame: 90 days
measure: Overall complication rate (grade 1 to 5)
timeFrame: 90 days
measure: Severe complication rate (grade 3 to 5)
timeFrame: 90 days
measure: Mortality (grade 5)
timeFrame: 90 days
measure: Overall duration of drainage
timeFrame: 90 days
measure: Overall length of stay
timeFrame: 90 days
measure: Re-admission rate
timeFrame: 90 days
measure: Cost effectiveness
timeFrame: 90 days
measure: Fistula according to possible new definition of the ISGPF group
timeFrame: 90 days
measure: Postoperative quality of life after pancreatic surgery
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: La Pitié Salpêtrière Hospital
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: La Pitié Salpêtrière Hospital, AP-HP
name: Sébastien GAUJOUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cochin Hospital, AP-HP
name: Bertrand DOUSSET, MD, PhD
role: STUDY_CHAIR
References: