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Completed

NCT Number: NCT03000946

Prevention of Postoperative Pancreatic Fistula by Somatostatin

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

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Key information

Conditions

Pancreatic Surgery Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreatic Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cochin Hospital, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatostatin

Drug

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

Other names: Somatostatine Eumedica

Octreotide

Drug

Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days

Other names: Siroctid

Primary outcomes

  1. ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification

    Time frame: 90 days

Secondary outcomes

  1. ≥grade 3 pancreatic complication rates (fistula, leak, and abscess)

    Time frame: 60 days

    as defined by the MSKCC surgical secondary events system

  2. Overall pancreatic fistula rate (grade A,B and C)

    Time frame: 90 days

    previous ISGPF classification

  3. Overall pancreatic fistula rate (grade B and C)

    Time frame: 90 days

    last ISGPF classification

  4. Overall complication rate (grade 1 to 5)

    Time frame: 90 days

    according to Clavien-Dindo classification

  5. Severe complication rate (grade 3 to 5)

    Time frame: 90 days

    according to Clavien-Dindo classification

  6. Mortality (grade 5)

    Time frame: 90 days

    according to Clavien-Dindo classification

  7. Overall duration of drainage

    Time frame: 90 days

    required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)

  8. Overall length of stay

    Time frame: 90 days

  9. Re-admission rate

    Time frame: 90 days

  10. Cost effectiveness

    Time frame: 90 days

  11. Fistula according to possible new definition of the ISGPF group

    Time frame: 90 days

  12. Postoperative quality of life after pancreatic surgery

    Time frame: 7 days after surgery

    only in patients undergoing pancreaticoduodenectomy

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: PREFIPS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2016
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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