1. 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
- Author
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Jad Abou Khalil, Ved Tandan, Anton I. Skaro, Fady Balaa, Yigang Luo, Guillaume Martel, Douglas Quan, Steven Gallinger, Pablo E. Serrano, K. Bertens, Natalie G. Coburn, Hpb Concept team, Sulaiman Nanji, Michael Marcaccio, Ramy Behman, Calvin Law, Gavin Beck, Deepak Dath, Julie Hallet, Michael A. J. Moser, Lev D. Bubis, Ken Leslie, Paul J. Karanicolas, and Rachel Roke
- Subjects
medicine.medical_specialty ,Intra operative ,Phases of clinical research ,030230 surgery ,Pancreatic Fistula ,03 medical and health sciences ,Pancreatectomy ,Postoperative Complications ,0302 clinical medicine ,Animals ,Humans ,Medicine ,Prospective Studies ,Post operative ,Pancreas ,Retrospective Studies ,Fixation (histology) ,Hepatology ,business.industry ,Incidence (epidemiology) ,Gastroenterology ,medicine.disease ,Surgery ,Pancreatic fistula ,030220 oncology & carcinogenesis ,Cattle ,business ,Distal pancreatectomy ,Pancreatic stump - 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).
- Published
- 2022
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