Pancreatic SurgerySTEREOPANCNCT07884019
Stereotactic Body Radiotherapy (SBRT) Induced Pancreatic Atrophy for Prevention of Post Operative Pancreatic Fistulae (POPF) After Pancreatoduodenectomy in Very High-Risk Patients (STEREOPANC)
A study testing Remnant pancreas SBRT in people with Pancreatic Surgery and Prophylactic SBRT, run by Oulu University Hospital at 3 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Surgery, Prophylactic SBRT, Pancreatic Leak
- What is being tested?
- Remnant pancreas SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesFinland
- Study dates
- 2 Mar 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland3 sites, 3 recruiting
- Not yet recruiting
Central Hospital of North Carelia
Joensuu
Lauri Pautola, MD, lauri.pautola@siunsote.fi
- Recruiting
Kuopio University Hospital
Kuopio
Antti Kivivuori, MD PhD, +358442593352, antti.kivivuori@pshyvinvointialue.fi
- Recruiting
Oulu University Hospital
Oulu
Minna Nortunen, MD PhD, +35883152875, minna.nortunen@pohde.fi
About this study
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
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.
Read the detailed description
Pancreatic fistula is a frequent (13-40%), and potentially life-threatening complication after pancreatic surgery. Most of the mortality after pancreatic surgery is attributable to failure to rescue after pancreatic leak. Soft texture of pancreatic parenchyma (OR = 4.24) and ≤ 3mm pancreatic duct (OR = 3.14) are the strongest predictors of clinically relevant postoperative pancreatic fistula. In very high-risk patients, with soft pancreas and MPD diameter ≤ 3mm, the risk of B/C fistula is exceedingly high, over 40%. Mortality associated with grade C fistula is as high as 25%.
Prolonged duct occlusion causes dilatation of the main pancreatic duct and pressure in the ducts and parenchyma. The enduring high pressure further results in fibrotic changes, exocrine and endocrine insufficiency, defined as athropy of the parenchyma (hard texture). Hard texture of the pancreas can be seen as a surrogate for athropic gland, which is the one absolute factor protecting from POPF: if the exocrine function has run dry, a B/C fistula cannot develop.
SBRT denotes a highly precise radiotherapy method. SBRT delivery techniques enable high doses to target volume and better protection for surrounding normal tissues when compared to conventional external radiation therapy. Radiotherapy induces fibrosis in target organs. We hypothesize, that SBRT directed at the remnant pancreas would cease the exocrine production of pancreas. When considering feasibility and toxicity, SBRT is directly linked to better quality of life due to lesser fractions, and grade 3 toxicity rates are significantly lower than with external RT.
The primary aim of the study is to evaluate the effect of preoperative remnant pancreas SBRT on the rate of B/C vs no preoperative intervention for very high-risk patients scheduled for pancreatoduodenectomy.
The secondary aims include extent of pancreatic fibrosis as assessed by magnetic resonance imaging (MRI) and EUS elastography, SBRT related early and late adverse events (CTCAE), complications of surgery (Clavien-Dindo), postoperative mortality, length of stay, readmissions, SBRT effects on endocrine and exocrine pancreatic function (pre SBRT vs post SBRT), cost analysis, and radiological and histopathological changes induced by SBRT.
- Conditions
- Pancreatic Surgery, Prophylactic SBRT, Pancreatic Leak
- Being tested
- Remnant pancreas SBRT
- Keywords
- pancreatic leak prevention, prophylactic SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remnant pancreas SBRTRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| SBRT arm | Experimental | Patients receive SBRT of 19,8Gy in three fractions of 6,6Gy to the remnant pancreas area 4-6weeks prior to pancreatoduodenectomy Receives: Radiation: Remnant pancreas SBRT |
| Control arm | No intervention | Patients undergo pancreatoduodenectomy according to standard protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative grade B/C pancreatic fistulae
B/C fistulae defined by ISGPS
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start2 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884019
- Sponsor's protocol ID
- EETTMK:20/2025
- Other IDs
- TUTK: 146/2025
- Acronym
- STEREOPANC
- Status last verified
- Mar 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07884019
- Acronym / sponsor ID
- STEREOPANC / EETTMK:20/2025
- Conditions
- Pancreatic Surgery, Prophylactic SBRT, Pancreatic Leak
- Keywords
- pancreatic leak prevention, prophylactic SBRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Kuopio University Hospital
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatic fistula is a frequent (13-40%), and potentially life-threatening complication after pancreatic surgery. Most of the mortality after pancreatic surgery is attributable to failure to rescue after pancreatic leak. Soft texture of pancreatic parenchyma (OR = 4.24) and ≤ 3mm pancreatic duct (OR = 3.14) are the strongest predictors of clinically relevant postoperative pancreatic fistula. In very high-risk patients, with soft pancreas and MPD diameter ≤ 3mm, the risk of B/C fistula is exceedingly high, over 40%. Mortality associated with grade C fistula is as high as 25%.
Prolonged duct occlusion causes dilatation of the main pancreatic duct and pressure in the ducts and parenchyma. The enduring high pressure further results in fibrotic changes, exocrine and endocrine insufficiency, defined as athropy of the parenchyma (hard texture). Hard texture of the pancreas can be seen as a surrogate for athropic gland, which is the one absolute factor protecting from POPF: if the exocrine function has run dry, a B/C fistula cannot develop.
SBRT denotes a highly precise radiotherapy method. SBRT delivery techniques enable high doses to target volume and better protection for surrounding normal tissues when compared to conventional external radiation therapy. Radiotherapy induces fibrosis in target organs. We hypothesize, that SBRT directed at the remnant pancreas would cease the exocrine production of pancreas. When considering feasibility and toxicity, SBRT is directly linked to better quality of life due to lesser fractions, and grade 3 toxicity rates are significantly lower than with external RT.
The primary aim of the study is to evaluate the effect of preoperative remnant pancreas SBRT on the rate of B/C vs no preoperative intervention for very high-risk patients scheduled for pancreatoduodenectomy.
The secondary aims include extent of pancreatic fibrosis as assessed by magnetic resonance imaging (MRI) and EUS elastography, SBRT related early and late adverse events (CTCAE), complications of surgery (Clavien-Dindo), postoperative mortality, length of stay, readmissions, SBRT effects on endocrine and exocrine pancreatic function (pre SBRT vs post SBRT), cost analysis, and radiological and histopathological changes induced by SBRT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT arm | Experimental | Radiation: Remnant pancreas SBRTPatients receive SBRT of 19,8Gy in three fractions of 6,6Gy to the remnant pancreas area 4-6weeks prior to pancreatoduodenectomy |
| Control arm | No intervention | –Patients undergo pancreatoduodenectomy according to standard protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remnant pancreas SBRTSBRT 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. | Radiation | SBRT arm |
Primary outcome
Rate of postoperative grade B/C pancreatic fistulae
Time frame: 90 days after surgery
B/C fistulae defined by ISGPS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remnant pancreas SBRT in people with Pancreatic Surgery and Prophylactic SBRT, run by Oulu University Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minna Nortunen, MD PhD (+35883152875, minna.nortunen@pohde.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative grade B/C pancreatic fistulae (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.