FIBROPANC-1: Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Intervention arm
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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.
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Outcome Measures
Primary Outcome Measures
- Safety - CTCAE grade 3-4-5 complications related to the intervention [Up to 30 days after surgery]
- Hardness of pancreas texture, determined by Durometer measurement [Histopathological assesment of tissue after surgery]
Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
Secondary Outcome Measures
- Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C [Up to 30 days after operation]
Defined by the ISGPS guideline (2016)
- Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon [Assesment during surgery]
Texture is scaled as soft/intermediate/hard
- Macroscopic tissue assessment, determined by the pathologist [Histopathological assesment after surgery]
Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue
- Surgery related postoperative complications defined according to the Clavien-Dindo classification [Up to 30 days after surgery]
- Overall complications [Up to 30 days after surgery]
- Readmission rate [Postoperative period]
- Length of hospital stay [Up to 30 days after surgery]
Days
- 30-day mortality and in-hospital mortality [Up to 30 days after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma.
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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).
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WHO-ECOG performance status 0,1 or 2.
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Ability to undergo stereotactic radiotherapy and surgery.
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Age ≥ 18 years.
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Good understanding of the oral and written patient information provided.
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Written informed consent.
Exclusion Criteria:
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Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region.
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Patients with (a history of) chronic pancreatitis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Amsterdam UMC | Amsterdam | North-Holland | Netherlands | |
2 | Erasmus Medical Center | Rotterdam | South-Holland | Netherlands |
Sponsors and Collaborators
- Erasmus Medical Center
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL72913.018.20