Status:
COMPLETED
Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Baxter Healthcare Corporation
Hamilton Health Sciences Corporation
Conditions:
Pancreas Cancer
Pancreas Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Despite improvements and advances in pancreas surgery, about 30-35% of patients who have pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic fistula occurs when f...
Eligibility Criteria
Inclusion
- Scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with or without splenectomy
- Age ≥ 18 years
- Able and willing to comply with study procedures and follow-up examinations contained within the written consent form
Exclusion
- Contraindication to placement of HEMOPATCH tissue sealant including: 1) Known hypersensitivity to bovine proteins; 2) Known hypersensitivity to brilliant blue \[FD\&C Blue No.1 (Blue 1)\]; 3) Presence of an active infection; and 4) Known pregnancy or lactation (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation)
- Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor)
Key Trial Info
Start Date :
August 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03410914
Start Date
August 13 2018
End Date
October 23 2020
Last Update
November 3 2021
Active Locations (7)
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1
Hamilton Health Sciences
Hamilton, Ontario, Canada
2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
4
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6