Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy (FIBROPANC-1)

Erasmus University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Pancreatic Fistula

Pancreas Fibrosis

Distal Cholangiocarcinoma

Duodenum Carcinoma

Pancreas Neoplasm

Neuroendocrine Carcinoma of Pancreas

GIST

Treatments

Radiation: Stereotactic radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05641233

NL72913.018.20

Details and patient eligibility

About

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.

Enrollment

33 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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