Clinical trial · Interventional
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Distal Cholangiocarcinoma | Distal Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Duodenum Carcinoma | — | UNRESOLVED | — |
| GIST | Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
| Neuroendocrine Carcinoma of Pancreas | — | UNRESOLVED | — |
| Pancreas Fibrosis | — | UNRESOLVED | — |
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatic Fistula | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention arm
- interventionNames
- Radiation: Stereotactic radiotherapy
Primary outcomes (2)
- measure
- Safety - CTCAE grade 3-4-5 complications related to the intervention
- timeFrame
- Up to 30 days after surgery
- measure
- Hardness of pancreas texture, determined by Durometer measurement
- timeFrame
- Histopathological assesment of tissue after surgery
- description
- Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSuurmeijer JA, Wismans LV, Hendriks TE, Bruynzeel AM, Nuyttens JJ, Intven MPW, van Driel LMJW, Groot Koerkamp B, Busch OR, Stoker JJ, Verheij J, Farina A, Doukas M, de Hingh IHJ, Lips DJ, van der Harst E, van Tienhoven G, Besselink MG, van Eijck CHJ; Dutch Pancreatic Cancer Group. Feasibility, safety and preliminary efficacy of preoperative stereotactic radiotherapy on the future pancreatic neck transection margin to reduce the risk of pancreatic fistula after high-risk pancreatoduodenectomy (FIBROPANC): protocol for a multicentre, single-arm trial. BMJ Open. 2024 Sep 24;14(9):e087193. doi: 10.1136/bmjopen-2024-087193. PMID 39317507