Prevention of Postoperative Pancreatic Fistula by Somatostatin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study

Conditions
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Pancreatic Surgery

Intervention / Treatment
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* Drug: Somatostatin
* Drug: Octreotide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatostatin<br>Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days | Drug: Somatostatin<br>* Lyophilisate and solution for IV use (glass ampoule of lyophilisate + 1 ml glass ampoule of solvent) 6 mg per day Continuous intravenous infusion for 6,5 days<br>* Other names: Somatostatine Eumedica;|
| Active Comparator: Octreotide<br>Subcutaneous octreotide 100 μg 3 times a day for 6.5 days. | Drug: Octreotide<br>* Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days<br>* Other names: Siroctid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥grade 3 pancreatic complication rates (fistula, leak, and abscess) | as defined by the MSKCC surgical secondary events system | 60 days | 
| Overall pancreatic fistula rate (grade A,B and C) | previous ISGPF classification | 90 days | 
| Overall pancreatic fistula rate (grade B and C) | last ISGPF classification | 90 days | 
| Overall complication rate (grade 1 to 5) | according to Clavien-Dindo classification | 90 days | 
| Severe complication rate (grade 3 to 5) | according to Clavien-Dindo classification | 90 days | 
| Mortality (grade 5) | according to Clavien-Dindo classification | 90 days | 
| Overall duration of drainage | required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed) | 90 days | 
| Overall length of stay |  | 90 days | 
| Re-admission rate |  | 90 days | 
| Cost effectiveness |  | 90 days | 
| Fistula according to possible new definition of the ISGPF group |  | 90 days | 
| Postoperative quality of life after pancreatic surgery | only in patients undergoing pancreaticoduodenectomy | 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatectomy, Somatostatin analogue, Octreotide, Pancreatic fistula