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Clinical Trials/NL-OMON21296
NL-OMON21296
Recruiting
Not Applicable

Preoperative radiotherapy in patients at very high risk of postoperative pancreatic fistula after pancreatoduodenectomy (FIBROPANC): a multicenter phase II study

A0 sites33 target enrollmentTBD
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ConditionsMalignant and premalignant periampullary tumors, excluding pancreatic adenocarcinoma.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant and premalignant periampullary tumors, excluding pancreatic adenocarcinoma.
Sponsor
A
Enrollment
33
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
A

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 pancreatitis
  • •\- Contra\-indications for MRI

Outcomes

Primary Outcomes

Not specified

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