NCT07370987

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Nov 2027

First Submitted

Initial submission to the registry

September 9, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

September 9, 2025

Last Update Submit

January 22, 2026

Conditions

Pancreatic FistulaPancreaticoduodenectomy

Keywords

Pancreatic fistulaSurgerypancreaticoduodenectomyRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 22

Secondary Outcomes (14)

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

    Week 22

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

    Week 22

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

    Week 10

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

    Week 10

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

    Day of surgery- Week 10

  • +9 more secondary outcomes

Study Arms (1)

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

Other: Stereotactic radiotherapy / pancreaticoduodenectomy

Interventions

Stereotactic radiotherapy / pancreaticoduodenectomyOTHER

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

Intervention group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of HPB Surgery, Hospital Pitié Salpétrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

RadiosurgeryPancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesDigestive System Surgical Procedures

Central Study Contacts

Sébastien GAUJOUX, PU/PH

CONTACT

+33184827972sebastien.gaujoux@aphp.fr

Charles DE PONTHAUD, PU/PH

CONTACT

charles.de-ponthaud@aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

January 27, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)