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Trial Title:
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
NCT ID:
NCT05641233
Condition:
Neuroendocrine Carcinoma of Pancreas
Duodenum Carcinoma
Pancreas Neoplasm
Distal Cholangiocarcinoma
GIST
Pancreas Fibrosis
Pancreatic Fistula
Conditions: Official terms:
Carcinoma
Cholangiocarcinoma
Carcinoma, Neuroendocrine
Pancreatic Neoplasms
Pancreatic Fistula
Fibrosis
Fistula
Conditions: Keywords:
Post operative pancreatic fistula
Stereotactic radiotherapy
Pancreatic fibrosis
Pancreatoduodenectomy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic radiotherapy
Description:
Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm
pancreas at the intended (i.e. future) anastomotic site.
Arm group label:
Intervention arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Tessa Hendriks
Email:
t.e.hendriks@amsterdamumc.nl
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Leonoor Wismans
Email:
l.wismans@erasmusmc.nl
Start date:
December 1, 2020
Completion date:
March 1, 2023
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05641233
