Christopher R Shubert1, Christina R Ferrone2, Carlos Fernandez-Del Castillo2, Michael L Kendrick1, Michael B Farnell1, Rory L Smoot1, Mark J Truty1, Florencia G Que3. 1. Mayo Clinic, Department of Surgery, Division of Subspecialty General Surgery, Section of Hepatobiliary and Pancreas Surgery, Rochester, Minnesota. 2. Department of Surgery, Massachusetts General Hospital and Harvard Medical School, General and Gastrointestinal Surgery, Boston, Massachusetts. 3. Mayo Clinic, Department of Surgery, Division of Subspecialty General Surgery, Section of Hepatobiliary and Pancreas Surgery, Rochester, Minnesota. Electronic address: que.florencia@mayo.edu.
Abstract
BACKGROUND: Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. METHODS: A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to eitherTissueLink or SEAMGUARD. RESULTS: Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula-related morbidity between the two groups. CONCLUSIONS: This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics.
RCT Entities:
BACKGROUND:Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. METHODS: A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. RESULTS: Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula-related morbidity between the two groups. CONCLUSIONS: This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics.
Authors: Christopher W Mangieri; Michael Kuncewitch; Brett Fowler; Richard A Erali; Omeed Moaven; Perry Shen; Clancy J Clark Journal: J Surg Oncol Date: 2020-07-02 Impact factor: 3.454
Authors: Felix J Hüttner; Pascal Probst; Hannes G Kenngott; Phillip Knebel; Thilo Hackert; Alexis Ulrich; Markus W Büchler; Markus K Diener Journal: PLoS One Date: 2018-10-16 Impact factor: 3.240