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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05641233
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Erasmus Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma, Pancreas Neoplasm, Distal Cholangiocarcinoma, GIST, Pancreas Fibrosis, Pancreatic Fistula

Arms & Interventions

Arms

Experimental: Intervention arm

Interventions

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.

Contact a Trial Team

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International Sites

Amsterdam UMC, Amsterdam, North-Holland, Netherlands

Status

Recruiting

Address

Amsterdam UMC

Amsterdam, North-Holland,

Site Contact

Tessa Hendriks

[email protected]

010-703 38 54

Erasmus Medical Center, Rotterdam, South-Holland, Netherlands

Status

Recruiting

Address

Erasmus Medical Center

Rotterdam, South-Holland,

Site Contact

Leonoor Wismans

[email protected]

010-703 38 54

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