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

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

Recruiting
18 years and older
All
Phase 1/2

Overview

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.

Eligibility

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

Print
Study details
    Neuroendocrine Carcinoma of Pancreas
    Duodenum Carcinoma
    Pancreas Neoplasm
    Distal Cholangiocarcinoma
    GIST
    Pancreas Fibrosis
    Pancreatic Fistula

NCT05641233

Erasmus Medical Center

13 December 2024

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