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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)

RecruitingNAAges 18 Years - anyAllOulu University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients scheduled to undergo pancreatoduodenectomy for any indication but no pancreatic duct occlusion * Pancreatic duct diameter โ‰ค 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 โ‰ฅ 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.)ยฌยฌ * 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
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What it tests

  • Remnant pancreas SBRT
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Where

3 sites
Central Hospital of North Carelia
Joensuu, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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