Preoperative Radiotherapy In Patients At High Risk Of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

Study Overview

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

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.

N/A

Neuroendocrine Carcinoma of Pancreas
Duodenum Carcinoma
Pancreas Neoplasm
Distal Cholangiocarcinoma
GIST
Pancreas Fibrosis
Pancreatic Fistula

RADIATION: Stereotactic radiotherapy

NL72913.018.20

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-11-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-11-29
First Submitted that Met QC Criteria 2022-11-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-12-07
First Posted (ACTUAL) 2022-12-07	Results First Posted N/A	Last Verified 2022-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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.

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.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Leonoor Wismans

Phone Number: 010-703 38 54

Email: l.wismans@erasmusmc.nl

Study Contact Backup

Name: Tessa Hendriks

Phone Number:

Email: t.e.hendriks@amsterdamumc.nl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record