Preoperative radiotherapy in patients at very high risk of postoperative pancreatic fistula after pancreatoduodenectomy (FIBROPANC): a multicenter phase II study

Recruiting

• Conditions: Malignant and premalignant periampullary tumors, excluding pancreatic adenocarcinoma.

• Registration Number: NL-OMON21296
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 33

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 pancreatitis
- Contra-indications for MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety (maximum of 3 patients with CTCAE grade 3-4-5 complications) and efficacy (significant change in the within-patient durometer measurements of radiated and non-radiated pancreatic texture) of preoperative radiotherapy.

Secondary Outcome Measures

Name	Time	Method
POPF Grade B and C