Preoperative SBRT to prevent pancreatic fistula after high-risk pancreatic surgery
Official title: Stereotactic Body Radiotherapy (SBRT) Induced Pancreatic Atrophy for Prevention of Post Operative Pancreatic Fistulae (POPF) After Pancreatoduodenectomy in Very High-Risk Patients (STEREOPANC): A Randomized Controlled Multicenter Study
Run by Oulu University Hospital · NCT07884019 · Data updated 2026-11-12
In people at very high risk of a pancreatic leak after pancreatoduodenectomy, this study tests whether giving a precise preoperative SBRT dose can reduce fistula risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Oulu University Hospital Academic / other |
| Drugs / interventions | radiation, methotrexate |
| Locations | 3 sites (Joensuu and 2 other locations) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | March 2029 |
| Study ends | July 2029 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07884019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with very high risk for fistula undergoing pancreatoduodenectomy, duct diameter ≤3 mm, soft pancreatic texture, and good performance status (WHO-ECOG 0-2).
✕Probably not a fit
Patients with dilated pancreatic ducts, prior radiotherapy to the target area, contraindications to SBRT, pregnancy, or inflammatory/ connective tissue disorders may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized, open-label study compares a preoperative SBRT regimen of 3 fractions of 6.6 Gy (total 19.8 Gy) to standard treatment in patients with soft pancreatic texture and small pancreatic duct who are scheduled for pancreatoduodenectomy. Eligible participants are adults with good functional status and no duct occlusion, recruited from Finnish centers. Primary focus is on whether SBRT can reduce clinically relevant pancreatic fistula and related complications by altering pancreatic tissue characteristics before surgery. The trial uses an interventional approach aimed at remnant pancreatic tissue and its exocrine function to influence postoperative outcomes.
Why it matters
Potential benefit: If successful, the approach could lower the rate of postoperative pancreatic fistula and associated mortality in high-risk patients.
How similar studies have gone: Previous data support feasibility of SBRT in pancreatic targets and its potential to induce fibrosis, but this exact preoperative approach for fistula prevention is investigational.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Kuopio University Hospital
Kuopio, Finland Recruiting -
Oulu University Hospital
Oulu, Finland Recruiting -
Central Hospital of North Carelia
Joensuu, Finland Not yet recruiting
Study contacts
- Study coordinator: Minna Nortunen, MD PhD
- Email: minna.nortunen@pohde.fi
- Phone: +35883152875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.