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Recruiting
NCT05641233
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Conditions: Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma, Pancreas Neoplasm, Distal Cholangiocarcinoma, GIST, Pancreas Fibrosis, Pancreatic Fistula
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1, PHASE2
Enrollment: 33
Sponsor: Erasmus Medical Center
Location: Netherlands
Summary
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 Criteria
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
Source: ClinicalTrials.gov (NCT05641233). StuddyBuddy aggregates publicly available trial information.