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- Title
Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial.
- Authors
Wang, Min; Pan, Shutao; Qin, Tingting; Xu, Xiaowu; Huang, Xiaobing; Liu, Jun; Chen, Xuemin; Zhao, Wenxing; Li, Jingdong; Liu, Chen; Li, Dewei; Liu, Jianhua; Liu, Yahui; Zhou, Baoyong; Zhu, Feng; Ji, Shunrong; Cheng, He; Li, Zheng; Li, Jing; Tang, Yichen
- Abstract
Key Points: Question: Does laparoscopic pancreaticoduodenectomy performed by experienced surgeons who surmounted the learning curve yield similar short-term outcomes to open pancreaticoduodenectomy in patients with pancreatic ductal adenocarcinoma? Findings: In this randomized clinical trial that included 200 patients with pancreatic ductal adenocarcinoma, laparoscopic pancreaticoduodenectomy yielded similar short-term outcomes to open pancreaticoduodenectomy, with comparable postoperative length of stay, postoperative surgical complications, number of lymph nodes harvested, and 90-day mortality. Meaning: For experienced pancreatic surgeons, performing laparoscopic pancreaticoduodenectomy in resectable pancreatic cancer was technically safe and did not increase the risk of intraoperative and postoperative complications in this study. This randomized clinical trial compares short-term outcomes among patients undergoing laparoscopic vs open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma. Importance: The safety and efficacy of laparoscopic pancreaticoduodenectomy for pancreatic ductal adenocarcinoma remain controversial. Objective: To compare laparoscopic and open pancreaticoduodenectomy performed by experienced surgeons in patients with pancreatic ductal adenocarcinoma. Design, Setting, and Participants: This was a noninferiority, open-label randomized clinical trial between September 20, 2019 and March 20, 2022, at 10 hospitals in China. A total of 412 adult patients were assessed for eligibility; 200 patients with histologically confirmed or clinically diagnosed pancreatic ductal adenocarcinoma who were eligible to undergo pancreaticoduodenectomy were enrolled. Study recruitment is complete, and follow-up is ongoing. This article reports prespecified early safety results from the trial. Interventions: Participants were randomized in a 1:1 ratio to undergo either laparoscopic or open pancreaticoduodenectomy, to be performed by experienced surgeons who had already performed at least 104 laparoscopic pancreaticoduodenectomy operations. Main Outcomes and Measures: The primary end point is 5-year overall survival, but the data for this end point are not yet mature; thus, secondary short-term outcomes, including operative findings, complications, mortality, and oncological results are reported here. The outcomes were analyzed according to a modified intention-to-treat and per-protocol principle. Results: Among 412 patients for eligibility, 200 patients were enrolled and randomly assigned 1:1 to have laparoscopic pancreaticoduodenectomy or open pancreaticoduodenectomy. The mean (SD) age was 61.3 (9.3) years, and 78 participants (39%) were female. Laparoscopic procedures had longer operative times (median [IQR], 330.0 [287.5-405.0] minutes vs 297.0 [245.0-340.0] minutes; P <.001). Patients in the laparoscopic group lost less blood than those in the open group (median [IQR], 145.0 [100.0-200.0] mL vs 200.0 [100.0-425.0] mL; P =.02). Ninety-day mortality occurred in 2 of 100 patients in the laparoscopic group and 0 of 100 patients in the open group. There was no difference in the rates of complications of the Clavien-Dindo grades III−IV (n = 17 [17.0%] vs n = 23 [23.0%]; P =.29), comprehensive complication index (median [IQR], 0.0 [0.0-22.6] vs 8.7 [0.0-26.2]; P =.79) or median (IQR) postoperative length of stay (14.0 [11.0-17.0] days vs 14.0 [12.0-18.5] days; P =.37) between the 2 groups. Conclusions and Relevance: Laparoscopic pancreaticoduodenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar short-term outcomes compared with open pancreaticoduodenectomy among patients with pancreatic ductal adenocarcinoma. Trial Registration: ClinicalTrials.gov Identifier: NCT03785743
- Publication
JAMA Surgery, 2023, Vol 158, Issue 12, p1245
- ISSN
2168-6254
- Publication type
Article
- DOI
10.1001/jamasurg.2023.5210