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Annals of surgery · 2023

Effect of Laparoscopic and Open Pancreaticoduodenectomy for Pancreatic or Periampullary Tumors: Three-year Follow-up of a Randomized Clinical Trial.

Рандомизированное исследованиеСтатьяEquivalence TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Qin Tingting, Zhang Hang, Pan Shutao, Liu Jun, Li Dewei, Chen Rufu, Huang Xiaobing, Liu Yahui, Liu Jianhua, Cheng Wei, Chen Xuemin, Zhao Wenxing, Li Jingdong, Tan Zhijian, Huang Heguang, Li Deyu, Zhu Feng, Yu Guangsheng, Zhou Baoyong, Zheng Shangyou, Tang Yichen, Ke Jianji, Liu Xueqing, Chen Botao, Chen Weibo, Ma Hongqin, Xu Jian, Liu Yifeng, Lin Ronggui, Dong Yadong, Yu Yahong, Wang Min, Qin Renyi, Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China’s International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM)

Аннотация

OBJECTIVE: This study aimed to estimate whether the potential short-term advantages of laparoscopic pancreaticoduodenectomy (LPD) could allow patients to recover in a more timely manner and achieve better long-term survival than with open pancreaticoduodenectomy (OPD) in patients with pancreatic or periampullary tumors.

BACKGROUND: LPD has been demonstrated to be feasible and may have several potential advantages over OPD in terms of shorter hospital stay and accelerated recovery than OPD.

METHODS: This noninferiority, open-label, randomized clinical trial was conducted in 14 centers in China. The initial trial included 656 eligible patients with pancreatic or periampullary tumors enrolled from May 18, 2018, to December 19, 2019. The participants were randomized preoperatively in a 1:1 ratio to undergo either LPD (n=328) or OPD (n=328). The 3-year overall survival (OS), quality of life, which was assessed using the 3-level version of the European Quality of Life-5 Dimensions, depression, and other outcomes were evaluated.

RESULTS: Data from 656 patients [328 men (69.9%); mean (SD) age: 56.2 (10.7) years] who underwent pancreaticoduodenectomy were analyzed. For malignancies, the 3-year OS rates were 59.1% and 54.3% in the LPD and OPD groups, respectively ( P =0.33, hazard ratio: 1.16, 95% CI: 0.86-1.56). The 3-year OS rates for others were 81.3% and 85.6% in the LPD and OPD groups, respectively ( P =0.40, hazard ratio: 0.70, 95% CI: 0.30-1.63). No significant differences were observed in quality of life, depression and other outcomes between the 2 groups.

CONCLUSION: In patients with pancreatic or periampullary tumors, LPD performed by experienced surgeons resulted in a similar 3-year OS compared with OPD.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03138213.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты