Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

Study Overview
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Brief Summary
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The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.

Official Title
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Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study

Conditions
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Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma, Pancreas Neoplasm, Distal Cholangiocarcinoma, GIST, Pancreas Fibrosis, Pancreatic Fistula

Intervention / Treatment
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* Radiation: Stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma. Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site). WHO-ECOG performance status 0,1 or 2. Ability to undergo stereotactic radiotherapy and surgery. Age ≥ 18 years. Good understanding of the oral and written patient information provided. Written informed consent. Exclusion Criteria: Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region. Patients with (a history of) chronic pancreatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br> | Radiation: Stereotactic radiotherapy<br>* Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - CTCAE grade 3-4-5 complications related to the intervention |  | Up to 30 days after surgery | 
| Hardness of pancreas texture, determined by Durometer measurement | Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO | Histopathological assesment of tissue after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C | Defined by the ISGPS guideline (2016) | Up to 30 days after operation | 
| Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon | Texture is scaled as soft/intermediate/hard | Assesment during surgery | 
| Macroscopic tissue assessment, determined by the pathologist | Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue | Histopathological assesment after surgery | 
| Surgery related postoperative complications defined according to the Clavien-Dindo classification |  | Up to 30 days after surgery | 
| Overall complications |  | Up to 30 days after surgery | 
| Readmission rate |  | Postoperative period | 
| Length of hospital stay | Days | Up to 30 days after surgery | 
| 30-day mortality and in-hospital mortality |  | Up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post operative pancreatic fistula, Stereotactic radiotherapy, Pancreatic fibrosis, Pancreatoduodenectomy