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Laparoscopic vs open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): A multicentre, patient-blinded, randomised controlled phase 2/3 trial

The Lancet: Gastroenterology & Hepatology Feb 06, 2019

van Hilst J, et al. - In this multicenter, patient-blinded, parallel-group, randomized controlled phase 2/3 trial, researchers evaluated whether laparoscopic pancreatoduodenectomy could lessen the time to functional recovery vs open pancreatoduodenectomy. Forty-two patients were randomized in the phase 2 part of the trial between May 13 and December 20, 2016. Investigators found that the median time to functional recovery was 10 days after laparoscopic pancreatoduodenectomy vs 8 days after open pancreatoduodenectomy. Laparoscopic pancreatoduodenectomy was correlated with more complication-related deaths vs open pancreatoduodenectomy, though it was not statistically significant, and no difference was found between groups in time to functional recovery. These safety concerns were unforeseen and disturbing, particularly when trained surgeons perform 20 or more pancreatoduodenectomies per year in centers. The results could have been impacted by experience, learning curve and annual volume.

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