Status:
COMPLETED
Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy
Lead Sponsor:
Hospital Miguel Servet
Collaborating Sponsors:
Aragon Health Science Institute
Conditions:
Pancreatic Fistula
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine the effect of the sealant patch Hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on pati...
Detailed Description
Pancreaticoduodenectomy (PD) is the most common surgical procedure to treat pancreatic tumors in the head of the pancreas and periampullary region, as well as benign processes such as chronic pancreat...
Eligibility Criteria
Inclusion
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score \< 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
Exclusion
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score \< 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03419676
Start Date
May 1 2018
End Date
February 10 2022
Last Update
February 11 2022
Active Locations (1)
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1
Mario Serradilla Martín
Zaragoza, Spain, 50008