Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy

A Single-arm Phase II Trial of Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy

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 fluid produced by the pancreas leaks into the abdomen after pancreas surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term consequences.We are studying the effect of a medical device named HEMOPATCH on the development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine protein-based pad that may improve tissue sealing where it is applied during surgery. Some small studies called case studies of between 2 and 7 patients, and two clinical trials have shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some types of surgery. However, there have been no completed clinical trials using HEMOPATCH to prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or leakage of other body fluids or air by standard surgical techniques are either ineffective or impractical.

Inclusion Criteria:

• 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 Criteria:

• 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)