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

Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Fistula; Pancreas Neoplasm; GIST; Neuroendocrine Carcinoma of Pancreas; Duodenum Carcinoma; Distal Cholangiocarcinoma; Pancreas Fibrosis
• Intervention / Treatment: Radiation: Stereotactic radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Leonoor Wismans; Phone Number: 010-703 38 54; Email: l.wismans@erasmusmc.nl
• Study Contact Backup: Name: Tessa Hendriks; Email: t.e.hendriks@amsterdamumc.nl

Study Locations

• Netherlands
  • North-Holland
    • Amsterdam, North-Holland, Netherlands
      • Recruiting
      • Amsterdam UMC
      • Contact: Tessa Hendriks; Email: t.e.hendriks@amsterdamumc.nl
  • South-Holland
    • Rotterdam, South-Holland, Netherlands
      • Recruiting
      • Erasmus Medical Center
      • Contact: Leonoor Wismans; Email: l.wismans@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm	Radiation: Stereotactic radiotherapy; Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO	Histopathological assesment of tissue after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Estimate): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Post operative pancreatic fistula; Stereotactic radiotherapy; Pancreatic fibrosis; Pancreatoduodenectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pathological Conditions, Anatomical; Pancreatic Diseases; Neuroendocrine Tumors; Digestive System Fistula; Fibrosis; Carcinoma; Fistula; Pancreatic Neoplasms; Cholangiocarcinoma; Pancreatic Fistula; Carcinoma, Neuroendocrine
• Other Study ID Numbers: NL72913.018.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No