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Stereotactic Body Radiotherapy (SBRT) Induced Pancreatic Atrophy for Prevention of Post Operative Pancreatic Fistulae (POPF) After Pancreatoduodenectomy in Very High-Risk Patients (STEREOPANC)

Sponsor: Oulu University Hospital • ClinicalTrials.gov ID: NCT07884019

Registry updated: 2026-10-20

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Description

STEREOPANC is a randomized, controlled, open label, multicenter study initiated by the Oulu HPB Study Group. Patients with a very high risk of B/C POPF (soft pancreas) scheduled for PD for any indication are recognized at a local HPB MDT. Patients are randomized to either intervention arm (preoperative SBRT in 3 x 6,6Gy fractions = 19.8 Gy) or control arm (conventional treatment) with a ratio of 1:1. Participating centers are Oulu University Hospital, Kuopio University Hospital and Central Hospital of Northern Carelia, Finland.

Interventions

Remnant pancreas SBRT (Radiation)
SBRT of 19.8Gy of the entire remnant pancreas in 3 fractions, delivered 4-6 weeks prior to pancreatoduodenectomy to patients with high -risk of POPF according to randomization.

Eligibility criteria

Inclusion Criteria: * Patients scheduled to undergo pancreatoduodenectomy for any indication but no pancreatic duct occlusion * 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 consen Exclusion Criteria: * Patients undergoing pancreatoduodenectomy with dilated duct \> 3mm * Patients with (a history of) chronic pancreatitis * Patients with contraindications to SBRT * Prior radiotherapy to the gross target area * Pregnancy * Connective tissue disorder (systemic lupus erythematosus, scleroderma etc) * Radiosensitizing medication that cannot be safely paused (methotrexate, post-transplant medications etc.)¬¬ * Inflammatory bowel disease * Inherited radiation hypersensitivity syndrome (ataxia-teleangiectasia mutation, ATM) * Inability to perform a light inspiration breath hold repeatedly (8-10 times 20s breath hold) * Severe allergy to contrast agents

Conditions

Pancreatic Surgery Prophylactic SBRT Pancreatic Leak

Locations

Central Hospital of North Carelia — Joensuu, Finland
Kuopio University Hospital — Kuopio, Finland
Oulu University Hospital — Oulu, Finland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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