Pancreatic SurgeryPhase 3PREFIPSNCT03000946
Prevention of Postoperative Pancreatic Fistula by Somatostatin
A Phase 3 study testing Somatostatin and Octreotide in people with Pancreatic Surgery, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Surgery
- What is being tested?
- Somatostatin and Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 2 sitesFrance
- Study dates
- 15 May 2017to 9 Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 years or greater
- Signed informed consent
- Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cochin Hospital
Paris, Paris, 75014
La Pitié Salpêtrière Hospital
Paris, 75013
About this study
Official title: Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study
The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula
Read the 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.
- Conditions
- Pancreatic Surgery
- Being tested
- Somatostatin, Octreotide
- Keywords
- Pancreatectomy, Somatostatin analogue, Octreotide, Pancreatic fistula
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Also called Somatostatine Eumedica
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
OctreotideDrug
Also called Siroctid
Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
| Study group | Role | What they receive |
|---|---|---|
| Somatostatin | Experimental | Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days Receives: Drug: Somatostatin |
| Octreotide | Active comparator | Subcutaneous octreotide 100 μg 3 times a day for 6.5 days. Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
Measured: 90 days
Secondary outcomes (12)
≥grade 3 pancreatic complication rates (fistula, leak, and abscess)
as defined by the MSKCC surgical secondary events system
Measured: 60 days
Overall pancreatic fistula rate (grade A,B and C)
previous ISGPF classification
Measured: 90 days
Overall pancreatic fistula rate (grade B and C)
last ISGPF classification
Measured: 90 days
Overall complication rate (grade 1 to 5)
according to Clavien-Dindo classification
Measured: 90 days
Severe complication rate (grade 3 to 5)
according to Clavien-Dindo classification
Measured: 90 days
Mortality (grade 5)
according to Clavien-Dindo classification
Measured: 90 days
Overall duration of drainage
required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
Measured: 90 days
Overall length of stay
Measured: 90 days
Re-admission rate
Measured: 90 days
Cost effectiveness
Measured: 90 days
Fistula according to possible new definition of the ISGPF group
Measured: 90 days
Postoperative quality of life after pancreatic surgery
only in patients undergoing pancreaticoduodenectomy
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start15 May 2017
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sébastien GAUJOUX, MD, PhD, Principal investigator, La Pitié Salpêtrière Hospital, AP-HPBertrand DOUSSET, MD, PhD, Study chair, Cochin Hospital, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000946
- Sponsor's protocol ID
- P150915
- Other IDs
- 2016-001673-32, 2016
- Acronym
- PREFIPS
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2016
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaujoux S, Regimbeau JM, Piessen G, Truant S, Foissac F, Barbier L, Buc E, Adham M, Fuks D, Deguelte S, Muscari F, Sulpice L, Vaillant JC, Schwarz L, Sa Cunha A, Muzzolini M, Dousset B, Sauvanet A; Collaborators. Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study. Ann Surg. 2024 Aug 1;280(2):179-187. doi: 10.1097/SLA.0000000000006313. Epub 2024 Apr 25.
PubMed 38662619
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03000946
- Acronym / sponsor ID
- PREFIPS / P150915
- Conditions
- Pancreatic Surgery
- Keywords
- Pancreatectomy, Somatostatin analogue, Octreotide, Pancreatic fistula
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 May 2017 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatostatin | Experimental | Drug: SomatostatinContinuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days |
| Octreotide | Active comparator | Drug: OctreotideSubcutaneous octreotide 100 μg 3 times a day for 6.5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 18 years or greater
- Signed informed consent
- Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatostatinAlso: Somatostatine EumedicaLyophilisate 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 | Drug | Somatostatin |
| OctreotideAlso: SiroctidSolution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days | Drug | Octreotide |
Primary outcome
≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
Time frame: 90 days
12 secondary outcomes
≥grade 3 pancreatic complication rates (fistula, leak, and abscess)
Time frame: 60 days
Overall pancreatic fistula rate (grade A,B and C)
Time frame: 90 days
Overall pancreatic fistula rate (grade B and C)
Time frame: 90 days
Overall complication rate (grade 1 to 5)
Time frame: 90 days
Severe complication rate (grade 3 to 5)
Time frame: 90 days
Mortality (grade 5)
Time frame: 90 days
Overall duration of drainage
Time frame: 90 days
Overall length of stay
Time frame: 90 days
Re-admission rate
Time frame: 90 days
Cost effectiveness
Time frame: 90 days
Fistula according to possible new definition of the ISGPF group
Time frame: 90 days
Postoperative quality of life after pancreatic surgery
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 38662619Gaujoux S, Regimbeau JM, Piessen G, Truant S, Foissac F, Barbier L, Buc E, Adham M, Fuks D, Deguelte S, Muscari F, Sulpice L, Vaillant JC, Schwarz L, Sa Cunha A, Muzzolini M, Dousset B, Sauvanet A; Collaborators. Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study. Ann Surg. 2024 Aug 1;280(2):179-187. doi: 10.1097/SLA.0000000000006313. Epub 2024 Apr 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien GAUJOUX, MD, PhD principal investigator
La Pitié Salpêtrière Hospital, AP-HP
Bertrand DOUSSET, MD, PhD study chair
Cochin Hospital, AP-HP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatostatin and Octreotide in people with Pancreatic Surgery, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.