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

Phase 1

Recruiting

• Conditions: Pancreatic Fistula; Pancreas Neoplasm; GIST; Pancreas Fibrosis; Duodenum Carcinoma; Neuroendocrine Carcinoma of Pancreas; Distal Cholangiocarcinoma
• Interventions: Radiation: Stereotactic radiotherapy

• Registration Number: NCT05641233
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-29
• Last Update Submitted: 2022-11-29
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• 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) chronic pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Stereotactic radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Safety - CTCAE grade 3-4-5 complications related to the intervention	Up to 30 days after surgery
Hardness of pancreas texture, determined by Durometer measurement	Histopathological assesment of tissue after surgery	Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO

Secondary Outcome Measures

Name	Time	Method
Overall complications	Up to 30 days after surgery
Readmission rate	Postoperative period
Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon	Assesment during surgery	Texture is scaled as soft/intermediate/hard
Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C	Up to 30 days after operation	Defined by the ISGPS guideline (2016)
Length of hospital stay	Up to 30 days after surgery	Days
30-day mortality and in-hospital mortality	Up to 30 days after surgery
Macroscopic tissue assessment, determined by the pathologist	Histopathological assesment after surgery	Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue
Surgery related postoperative complications defined according to the Clavien-Dindo classification	Up to 30 days after surgery

Trial Locations

Locations (2)

Amsterdam UMC; 🇳🇱 Amsterdam, North-Holland, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, South-Holland, Netherlands