A Phase 1/2 interventional study of Stereotactic radiotherapy in Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma and Pancreas Neoplasm, sponsored by Erasmus Medical Center. Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Erasmus Medical Center · Phase 1/2, Interventional, and Prevention
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 33 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Safety - CTCAE grade 3-4-5 complications related to the intervention
Time frame: Up to 30 days after surgery
Hardness of pancreas texture, determined by Durometer measurement
Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
Time frame: Histopathological assesment of tissue after surgery
Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C
Defined by the ISGPS guideline (2016)
Time frame: Up to 30 days after operation
Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon
Texture is scaled as soft/intermediate/hard
Time frame: Assesment during surgery
Macroscopic tissue assessment, determined by the pathologist
Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue
Time frame: Histopathological assesment after surgery
Surgery related postoperative complications defined according to the Clavien-Dindo classification
Time frame: Up to 30 days after surgery
Overall complications
Time frame: Up to 30 days after surgery
Readmission rate
Time frame: Postoperative period
Length of hospital stay
Days
Time frame: Up to 30 days after surgery
30-day mortality and in-hospital mortality
Time frame: Up to 30 days after surgery
Plan to share: No
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This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center