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NCT Number: NCT07370987

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.

* 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

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of HPB Surgery, Hospital Pitié Salpétrière

Paris, 75013, France

Location status: Recruiting

Location contact

Charles DE PONTHAUD, PU-PH

CONTACT

[email protected]

Sébastien GAUJOUX, PU-PH

CONTACT

[email protected]

+33184827972

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Stereotactic radiotherapy / pancreaticoduodenectomy

Other

A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy Surgery : pancreaticoduodenectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. To assess overall surgical complication rate at W22 (90 days after surgery)

    Time frame: Week 22

    defined as a grade 1 to 5 according to the Dindo-Clavien classification complications occurring within 3 month from surgery

  2. To assess severe surgical complication rate at W22 (90 days after surgery)

    Time frame: Week 22

    defined as a grade 3 to 5 according to the Dindo-Clavien classification complications occurring within 3 month from surgery

  3. To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection with a durometer

    Time frame: Week 10

    determined intraoperatively by Durometer measurement of the radiated and irradiated pancreatic tissue in Shore OO

  4. To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection by the surgeon

    Time frame: Week 10

    Determined intraoperatively by the pancreatic surgeon. Texture is scaled as soft/intermediate/hard at W10

  5. To assess, during surgery (W10), technical difficulties added by radiotherapy, according to the surgeon

    Time frame: Day of surgery- Week 10

    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)

  6. To assess on a pathological point of view the resected specimen at W14

    Time frame: Day of surgery-week 14

    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

  7. To assess on a pathological point of view the resected specimen at W14

    Time frame: Day of surgery-week 14

    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)

  8. Pancreatic functionnal outcomes at W22 (de novo diabetes)

    Time frame: Week 22

    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%

  9. Pancreatic functionnal outcomes at W22 (exocrine pancreatic insufficiency)

    Time frame: Week 22

    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

  10. To assess mortality rate at W22

    Time frame: Week 22

  11. To assess overall length of hospital stay after surgery

    Time frame: Up to Week 34

    Length of hospital stay between the operation and the day of discharge from hospital

  12. To assess readmission rate at W22

    Time frame: Week 22

    Proportion of readmission at W22, whatever the cause

  13. 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 CTCAE classification (Common Terminology Criteria for Adverse Events), overall and by grade (grade 1 to 5)

  14. To assess safety of radiotherapy at W9, and W34

    Time frame: Week 9 and Week 34

    Proportion of patients at W9 and W34 who underwent at least one side effects of radiotherapy among gastritis or gastric bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Charles DE PONTHAUD, PU/PH

CONTACT

[email protected]

Sébastien GAUJOUX, PU/PH

CONTACT

[email protected]

+33184827972

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial

Acronym: PreFiR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

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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