Pancreatic FistulaPhase 2PreFiRNCT07370987
Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial
A Phase 2 study testing Stereotactic radiotherapy / pancreaticoduodenectomy in people with Pancreatic Fistula and Pancreaticoduodenectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Pancreatic Fistula, Pancreaticoduodenectomy
- What is being tested?
- Stereotactic radiotherapy / pancreaticoduodenectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 45 years old
- Candidate for pancreaticoduodenectomy by laparotomy
- Body mass index (BMI) ≥ 25kg/m2
- Diameter of main pancreatic duct (MPD) < 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area)
- Affiliation to a social security system (AME excepted)
- Signed informed consent
Who cannot join
- Surgery indication : Chronic pancreatitis
- Surgery indication : Pancreatic ductal adenocarcinoma
- History of syndromic or hereditary pancreatic tumor
- Contraindication to pancreaticoduodenectomy
- Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy
- Planned external drainage of the main pancreatic duct at the end of the surgery
Show all 20Show fewer
- Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy
- History of chronic hepatitis (F3) or cirrhosis (F4)
- Contraindication to radiotherapy
- Previous history of abdominal radiotherapy
- Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus)
- History of complicated peptic ulcer
- Patient treated for less than 4 weeks for an ulcer
- History of pancreatic surgery
- Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control
- Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator
- Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study
- Treatment with systemic corticosteroids (excluding inhaled corticosteroids)
- Participation in another interventional clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study
- Protected persons under legal guardianship or conservatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charles DE PONTHAUD, PU/PH contact
France1 site, 1 recruiting
- Recruiting
Department of HPB Surgery, Hospital Pitié Salpétrière
Paris, 75013
Sébastien GAUJOUX, PU-PH, +33184827972, sebastien.gaujoux@aphp.fr
Charles DE PONTHAUD, PU-PH, charles.de-ponthaud@aphp.fr
About this study
Official title: Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial
Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments.
Implementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records.
Read more
- Inclusion visit at the first surgical consultation (W-3 to D1) (V0) The inclusion visit will be done by the surgeon within 3 weeks before the first radiation oncologist visit
- D1 (V1): first radiation oncologist visit
- W2 (+/- 3D) and W4 (+/- 3D) (V2 et V3): Preoperative simulation process and treatment delivery
- A first visit at W+2 (+/- 3 D) will be mandatory to validate the positioning of the target volume by CBCT with IV constrast or MRI
- Then to start of the administration of radiotherapy at W+4 (+/- 3 D): Radiotherapy with 20 Gy, in 2 fraction of 10Gy with a one-day gap, so over a total period of 3
W9 ( +/- 1W) (V4): post-radiotherapy follow-up
- Preoperative visit Day-1 before PD (V5)
W10 (+/- 1W) (V6):
- Pancreaticoduodenectomy and post operative hospitalisation W14 (+/- 1W) (V7): follow up with surgeon (30 days after pancreaticoduodenectomy)
- W22 (+/-1W) (V8): follow up with surgeon (90 days after pancreaticoduodenectomy)
- W34 (+/-1W) (V9): Last study visit (radiation oncologist) (6 months after pancreaticoduodenectomy) Medical follow-up by radiation oncologist at 6 months after surgery to assess the occurrence of potential late toxicities due to radiotherapy
- Conditions
- Pancreatic Fistula, Pancreaticoduodenectomy
- Being tested
- Stereotactic radiotherapy / pancreaticoduodenectomy
- Keywords
- Pancreatic fistula, Surgery, pancreaticoduodenectomy, Radiotherapy
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapy / pancreaticoduodenectomyOther
A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy Surgery : pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | All patients enrolled in the trial and responding to inclusion/exclusion criteria will receive A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy targeting the isthmus of the pancreas over a 4 cm area that corresponds to the future anastomosis zone Receives: Other: Stereotactic radiotherapy / pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF)
Postoperative fistula grade B and C is defined according to the last ISGPS classification of 2016 and will be adjudicated by independant experts.
Measured: Week 22
Secondary outcomes (14)
To assess overall surgical complication rate at W22 (90 days after surgery)
defined as a grade 1 to 5 according to the Dindo-Clavien classification complications occurring within 3 month from surgery
Measured: Week 22
To assess severe surgical complication rate at W22 (90 days after surgery)
defined as a grade 3 to 5 according to the Dindo-Clavien classification complications occurring within 3 month from surgery
Measured: Week 22
To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection with a durometer
determined intraoperatively by Durometer measurement of the radiated and irradiated pancreatic tissue in Shore OO
Measured: Week 10
To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection by the surgeon
Determined intraoperatively by the pancreatic surgeon. Texture is scaled as soft/intermediate/hard at W10
Measured: Week 10
To assess, during surgery (W10), technical difficulties added by radiotherapy, according to the surgeon
Determined by 2 questions
- To what extent was the surgery complicated by the radiotherapy? (Answers: 1 - not complicated; 2 - slightly complicated; 3 - clearly complicated; 4 - severely complicated; 5 - impossible)
- Did you have to adapt the surgical plan due to the administration of radiotherapy? (Answers: Yes/No)
Measured: Day of surgery- Week 10
To assess on a pathological point of view the resected specimen at W14
determined by the pathologist by evaluation of macroscopic differences between radiated and irradiated pancreatic tissue.
- The extent and distribution of fibrosis and fat infiltration were evaluated using the score established by Rebours et al. in intra- and extralobular locations
Measured: Day of surgery-week 14
To assess on a pathological point of view the resected specimen at W14
determined by the pathologist by evaluation of macroscopic differences between radiated and irradiated pancreatic tissue.
- Fibrosis quantification was also assessed by determining the area of collagen using Sirius red staining (as performed in FIBROPANC trial)
Measured: Day of surgery-week 14
Pancreatic functionnal outcomes at W22 (de novo diabetes)
Determined by
- De novo diabetes : In accordance with French and European recommendations, diabetes is diagnosed if fasting blood glucose is greater than or equal to 1.26 g/L on two occasions, or greater than or equal to 2 g/L at any time of the day, or if HbA1c is greater than 6.5%
Measured: Week 22
Pancreatic functionnal outcomes at W22 (exocrine pancreatic insufficiency)
Determined by
- Exocrine pancreatic insufficiency: A fecal elastase level < 100 mg/g stool is commonly accepted for diagnosing severe exocrine pancreatic insufficiency, a fecal elastase level between 100 and 200 mg/g indicates moderate exocrine pancreatic insufficiency, and a level > 200 mg/g stool rules out exocrine pancreatic insufficiency
Measured: Week 22
To assess mortality rate at W22
Measured: Week 22
To assess overall length of hospital stay after surgery
Length of hospital stay between the operation and the day of discharge from hospital
Measured: Up to Week 34
To assess readmission rate at W22
Proportion of readmission at W22, whatever the cause
Measured: Week 22
To assess radiation-induced complications rate, overall and by grade at W9, W10, W14, W22, W34
to CTCAE classification (Common Terminology Criteria for Adverse Events), overall and by grade (grade 1 to 5)
Measured: Week 9, Week 10, Week 14, Week 22 and Week 34
To assess safety of radiotherapy at W9, and W34
Proportion of patients at W9 and W34 who underwent at least one side effects of radiotherapy among gastritis or gastric bleeding
Measured: Week 9 and Week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370987
- Sponsor's protocol ID
- APHP240932
- Other IDs
- IDRCB : 2025-A00206-43
- Acronym
- PreFiR
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07370987
- Acronym / sponsor ID
- PreFiR / APHP240932
- Conditions
- Pancreatic Fistula, Pancreaticoduodenectomy
- Keywords
- Pancreatic fistula, Surgery, pancreaticoduodenectomy, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- 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.
Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments.
Implementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records.
- Inclusion visit at the first surgical consultation (W-3 to D1) (V0) The inclusion visit will be done by the surgeon within 3 weeks before the first radiation oncologist visit
- D1 (V1): first radiation oncologist visit
- W2 (+/- 3D) and W4 (+/- 3D) (V2 et V3): Preoperative simulation process and treatment delivery
- A first visit at W+2 (+/- 3 D) will be mandatory to validate the positioning of the target volume by CBCT with IV constrast or MRI
- Then to start of the administration of radiotherapy at W+4 (+/- 3 D): Radiotherapy with 20 Gy, in 2 fraction of 10Gy with a one-day gap, so over a total period of 3
W9 ( +/- 1W) (V4): post-radiotherapy follow-up
- Preoperative visit Day-1 before PD (V5)
W10 (+/- 1W) (V6):
- Pancreaticoduodenectomy and post operative hospitalisation W14 (+/- 1W) (V7): follow up with surgeon (30 days after pancreaticoduodenectomy)
- W22 (+/-1W) (V8): follow up with surgeon (90 days after pancreaticoduodenectomy)
- W34 (+/-1W) (V9): Last study visit (radiation oncologist) (6 months after pancreaticoduodenectomy) Medical follow-up by radiation oncologist at 6 months after surgery to assess the occurrence of potential late toxicities due to radiotherapy
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Stereotactic radiotherapy / pancreaticoduodenectomyAll patients enrolled in the trial and responding to inclusion/exclusion criteria will receive A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy targeting the isthmus of the pancreas over a 4 cm area that corresponds to the future anastomosis zone |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 45 years old
- Candidate for pancreaticoduodenectomy by laparotomy
- Body mass index (BMI) ≥ 25kg/m2
- Diameter of main pancreatic duct (MPD) < 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area)
- Affiliation to a social security system (AME excepted)
Key exclusion criteria (20 listed)
- Surgery indication : Chronic pancreatitis
- Surgery indication : Pancreatic ductal adenocarcinoma
- History of syndromic or hereditary pancreatic tumor
- Contraindication to pancreaticoduodenectomy
- Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy
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 |
|---|---|---|
| Stereotactic radiotherapy / pancreaticoduodenectomyA dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy Surgery : pancreaticoduodenectomy | Other | Intervention group |
Primary outcome
Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF)
Time frame: Week 22
Postoperative fistula grade B and C is defined according to the last ISGPS classification of 2016 and will be adjudicated by independant experts.
14 secondary outcomes
To assess overall surgical complication rate at W22 (90 days after surgery)
Time frame: Week 22
To assess severe surgical complication rate at W22 (90 days after surgery)
Time frame: Week 22
To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection with a durometer
Time frame: Week 10
To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection by the surgeon
Time frame: Week 10
To assess, during surgery (W10), technical difficulties added by radiotherapy, according to the surgeon
Time frame: Day of surgery- Week 10
To assess on a pathological point of view the resected specimen at W14
Time frame: Day of surgery-week 14
To assess on a pathological point of view the resected specimen at W14
Time frame: Day of surgery-week 14
Pancreatic functionnal outcomes at W22 (de novo diabetes)
Time frame: Week 22
Pancreatic functionnal outcomes at W22 (exocrine pancreatic insufficiency)
Time frame: Week 22
To assess mortality rate at W22
Time frame: Week 22
To assess overall length of hospital stay after surgery
Time frame: Up to Week 34
To assess readmission rate at W22
Time frame: Week 22
To assess radiation-induced complications rate, overall and by grade at W9, W10, W14, W22, W34
Time frame: Week 9, Week 10, Week 14, Week 22 and Week 34
To assess safety of radiotherapy at W9, and W34
Time frame: Week 9 and Week 34
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- 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.
Charles DE PONTHAUD, PU/PH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic radiotherapy / pancreaticoduodenectomy in people with Pancreatic Fistula and Pancreaticoduodenectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien GAUJOUX, PU/PH (+33184827972, sebastien.gaujoux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF) (time frame: Week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.