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Yoon, Yoo-Seok MD, PhDa; Lee, Woohyung MD, PhDb; Kang, Chang Moo MD, PhDc; Hong, Taeho MD, PhDd; Shin, Sang Hyun MD, PhDe; Lee, Jung Woo MD, PhDf; Hwang, Dae Wook MD, PhDb; Song, Ki Byung MD, PhDb; Kwon, Jae Woo MD, PhDg; Sung, Min Kyu MD, PhDb; Shim, In Kyong MD, PhDh; Lee, Jung Bok PhDi; Kim, Song Cheol MD, PhDb,*
aDepartment of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea
bDivision of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Brain Korea 21 Project, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
cDivision of HBP surgery, Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea
dDivision of Hepato-biliary and Pancreas Surgery, Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
eDepartment of Surgery, Samsung Medical center, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea
fDepartment of Surgery, Hallym University, Sacred Heart Hospital, Dongtan, Republic of Korea
gDepartment of Surgery, Kangbuk Samsung Medical center, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea
hBiomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea
iDepartment of Clinical Epidemiology and Biostatistics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
Drs. Yoo-Seok Yoon, Woohyung Lee and Chang Moo Kang contributed equally to this work as first authors.
*Corresponding author. : Song Cheol Kim
Abstract
Background: There is a lack of robust evidence on the efficacy of laparoscopic pancreatoduodenectomy compared to open surgery. This study was aimed to compare time to functional recovery (FR) between laparoscopic and open pancreatoduodenectomy.
Materials and methods: This pragmatic, multicenter, randomized controlled phase 3 trial was conducted in seven tertiary centers. Patients with periampullary tumors were randomized using a block design in a 1:1 ratio and stratified by pancreatic fistula risk. Participants were randomized to undergo open or laparoscopic pancreatoduodenectomy by expert pancreatic surgeons. The primary outcome was the time to FR, defined as the number of days until FR was achieved in all five domains. The secondary endpoints included perioperative and short-term oncological outcomes.
Results: Between March 2019 and June 2022, 252 patients were randomly assigned to the laparoscopic (n=125) or open groups (n=127). Primary outcomes were reported in 235 patients. The mean time to FR was shorter in laparoscopic group compared to the open group (7.7 d vs. 9.0 d, P=0.03). Laparoscopic group exhibited a higher cumulative rate of FR compared to the open group (Hazard ratio,1.34; 95% confidence interval, 1.03-1.74; P=0.02). Severe complications, R0 resection, the number of retrieved lymph nodes and short-term survival rates were comparable between the two groups.
Conclusion: Laparoscopic pancreatoduodenectomy demonstrated modest advantages in FR time over open surgery for selected patients with experienced surgeons.
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