PATCH-DP: 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
Lev D Bubis, Ramy Behman, Rachel Roke, Pablo E Serrano, Jad A Khalil, Natalie G Coburn, Calvin H Law, Kimberly Bertens, Guillaume Martel, Julie Hallet, Michael Marcaccio, Fady Balaa, Douglas Quan, Steven Gallinger, Sulaiman Nanji, Ken Leslie, Ved Tandan, Yigang Luo, Gavin Beck, Anton Skaro, Deepak Dath, Michael Moser, Paul J Karanicolas, HPB CONCEPT team, Lev D Bubis, Ramy Behman, Rachel Roke, Pablo E Serrano, Jad A Khalil, Natalie G Coburn, Calvin H Law, Kimberly Bertens, Guillaume Martel, Julie Hallet, Michael Marcaccio, Fady Balaa, Douglas Quan, Steven Gallinger, Sulaiman Nanji, Ken Leslie, Ved Tandan, Yigang Luo, Gavin Beck, Anton Skaro, Deepak Dath, Michael Moser, Paul J Karanicolas, HPB CONCEPT team
Abstract
Background: Post-operative pancreatic fistula (POPF) is the most significant cause of morbidity following distal pancreatectomy. Hemopatch™ is a thin, bovine collagen-based hemostatic sealant. We hypothesized that application of Hemopatch™ to the pancreatic stump following distal pancreatectomy would decrease the incidence of clinically-significant POPF.
Methods: We conducted a prospective, single-arm, multicentre phase II study of application of Hemopatch™ to the pancreatic stump following distal pancreatectomy. The primary outcome was clinically-significant POPF within 90 days of surgery. A sample size of 52 patients was required to demonstrate a 50% relative reduction in Grade B/C POPF from a baseline incidence of 20%, with a type I error of 0.2 and power of 0.75. Secondary outcomes included incidence of POPF (all grades), 90-day mortality, 90-day morbidity, re-interventions, and length of stay.
Results: Adequate fixation Hemopatch™ to the pancreatic stump was successful in all cases. The rate of grade B/C POPF was 25% (95%CI: 14.0-39.0%). There was no significant difference in the incidence of grade B/C POPF compared to the historical baseline (p = 0.46). The 90-day incidence of Clavien-Dindo grade ≥3 complications was 26.9% (95%CI: 15.6-41.0%).
Conclusion: The use of Hemopatch™ was not associated with a decreased incidence of clinically-significant POPF compared to historical rates. (NCT03410914).
Copyright © 2021 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.
Source: PubMed