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
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)
Surgery indication : Chronic pancreatitis
Surgery indication : Pancreatic ductal adenocarcinoma
History of syndromic or hereditary pancreatic tumor
Contraindication to pancreaticoduodenectomy
Single group
Stereotactic radiotherapy / pancreaticoduodenectomy
Other interventionA dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy Surgery : pancreaticoduodenectomy
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.
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
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
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
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
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