Trials / Unknown
UnknownNCT05641233
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
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
- Neuroendocrine Carcinoma of Pancreas
- Duodenum Carcinoma
- Pancreas Neoplasm
- Distal Cholangiocarcinoma
- GIST
- Pancreas Fibrosis
- Pancreatic Fistula
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Stereotactic radiotherapy | Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site. |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2022-12-07
- Last updated
- 2022-12-07
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05641233. Inclusion in this directory is not an endorsement.