Preoperative radiotherapy in patients at very high risk of postoperative pancreatic fistula after pancreatoduodenectomy (FIBROPANC-1): a multicenter phase II study

Preoperative radiotherapy in patients at very high risk of postoperative pancreatic fistula after pancreatoduodenectomy (FIBROPANC-1): a multicenter phase II study - FIBROPANC-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54875

Enrollment

Registered

2020-07-21

Start date

2021-02-08

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(pre)malignant tumors in periampular region

Interventions

Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma. - Pancreatic duct diameter

Exclusion criteria

Exclusion criteria: - Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region. - Contra-indications for MRI (only for VUmc and UMCU), (e.g. presence of a pacemaker or defibrillator, metal splinters).

Design outcomes

Primary

Measure	Time frame
The main aim of this study are both to determine the safety (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. If both criteria for safety and efficacy are met, the endpoint POPF Grade B and C is assessed in 13 more patients, totalling 33 patients.	—

Measure

Time frame

The main aim of this study are both to determine the safety (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. If both criteria for safety and efficacy are met, the endpoint POPF Grade B and C is assessed in 13 more patients, totalling 33 patients.

—

Secondary

Measure	Time frame
The main secondary outcome is the postoperative occurrence of postoperative fistula grade B or C. Other outcomes: Overall complications Duration of admission in days Readmission rate	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)