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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB : 2025-A00206-43 | Other Identifier | ANSM |
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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.
W9 ( +/- 1W) (V4): post-radiotherapy follow-up
- Preoperative visit Day-1 before PD (V5)
W10 (+/- 1W) (V6):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 22 |
| To assess severe surgical complication rate at W22 (90 days after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sébastien GAUJOUX, PU/PH | Contact | +33184827972 | sebastien.gaujoux@aphp.fr | |
| Charles DE PONTHAUD, PU/PH | Contact | charles.de-ponthaud@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of HPB Surgery, Hospital Pitié Salpétrière | Recruiting | Paris | 75013 | France |
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defined as a grade 3 to 5 according to the Dindo-Clavien classification complications occurring within 3 month from surgery |
| 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 | 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 | Week 10 |
| To assess, during surgery (W10), technical difficulties added by radiotherapy, according to the surgeon | Determined by 2 questions
| 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 | 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) | 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% | 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 | Week 22 |
| To assess mortality rate at W22 | 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 | Up to Week 34 |
| To assess readmission rate at W22 | Proportion of readmission at W22, whatever the cause | 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) | 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 | Week 9 and Week 34 |
| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013505 | Digestive System Surgical Procedures |
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