Min Wang1, Dewei Li2, Rufu Chen3, Xiaobing Huang4, Jing Li5, Yahui Liu6, Jianhua Liu7, Wei Cheng8, Xuemin Chen9, Wenxing Zhao10, Jingdong Li5, Zhijian Tan11, Heguang Huang12, Deyu Li2, Feng Zhu1, Tingting Qin1, Jingdong Ma13, Guangsheng Yu14, Baoyong Zhou15, Shangyou Zheng3, Yichen Tang4, Wei Han16, Lingyu Meng16, Jianji Ke16, Feng Feng17, Botao Chen8, Xinmin Yin8, Weibo Chen9, Hongqin Ma10, Jian Xu18, Yifeng Liu6, Ronggui Lin12, Yadong Dong19, Yahong Yu1, Jun Liu7, Hang Zhang1, Renyi Qin20. 1. Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. 2. Department of Hepatobiliary Surgery, First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China; Department of Hepatobiliary and Pancreatic Oncology, Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, China; Department of Hepatobiliary Pancreatic Surgery, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan Province, China. 3. Department of General Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong Province, China; Department of Hepatobiliary Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China. 4. Department of Pancreatic-Hepatobiliary Surgery, The Second Affiliated Hospital, Army Medical University, People's Liberation Army, Chongqing, Chongqing Municipality, China. 5. Department of Pancreatic-Hepatobiliary Surgery, The Second Affiliated Hospital, Army Medical University, People's Liberation Army, Chongqing, Chongqing Municipality, China; Department of Hepatobiliary Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China. 6. Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun, Jilin Province, China; Department of Hepatobiliary and Pancreatic Surgery, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong Province, China. 7. Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China; Department of Hepato-Pancreato-Biliary Surgery, Shandong Provincial Hospital, Shandong First Medical University, Jinan, Shandong Province, China. 8. Department of Hepatobiliary Surgery, The First Affiliated Hospital of Hunan Normal University, Hunan Provincial People's Hospital, Changsha, Hunan Province, China. 9. Department of Hepatopancreatobiliary Surgery, The Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu Province, China. 10. Department of Hepato-Pancreato-Biliary Surgery, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province, China. 11. Department of Hepatobiliary and Pancreatic Surgery, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong Province, China. 12. Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China. 13. School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. 14. Department of Hepato-Pancreato-Biliary Surgery, Shandong Provincial Hospital, Shandong First Medical University, Jinan, Shandong Province, China. 15. Department of Hepatobiliary Surgery, First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China. 16. Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun, Jilin Province, China. 17. Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. 18. Department of Hepatobiliary Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China. 19. Department of Hepatobiliary Pancreatic Surgery, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan Province, China. 20. Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. Electronic address: ryqin@tjh.tjmu.edu.cn.
Abstract
BACKGROUND: The benefit and safety of laparoscopic pancreatoduodenectomy (LPD) for the treatment of pancreatic or periampullary tumours remain controversial. Studies have shown that the learning curve plays an important role in LPD, yet there are no randomised studies on LPD after the surgeons have surmounted the learning curve. The aim of this trial was to compare the outcomes of open pancreatoduodenectomy (OPD) with those of LPD, when performed by experienced surgeons. METHODS: In this multicentre, open-label, randomised controlled trial done in 14 Chinese medical centres, we recruited patients aged 18-75 years with a benign, premalignant, or malignant indication for pancreatoduodenectomy. Eligible patients were randomly assigned (1:1) to undergo either LPD or OPD. Randomisation was centralised via a computer-generated system that used a block size of four. The patients and surgeons were unmasked to study group, whereas the data collectors, outcome assessors, and data analysts were masked. LPD and OPD were performed by experienced surgeons who had already done at least 104 LPD operations. The primary outcome was the postoperative length of stay. The criteria for discharge were based on functional recovery, and analyses were done on a modified intention-to-treat basis (ie, including patients who had a pancreatoduodenectomy regardless of whether the operation was the one they were assigned to). This trial is registered with Clinicaltrials.gov, number NCT03138213. FINDINGS: Between May 18, 2018, and Dec 19, 2019, we assessed 762 patients for eligibility, of whom 656 were randomly assigned to either the LPD group (n=328) or the OPD group (n=328). 31 patients in each group were excluded and 80 patients crossed over (33 from LPD to OPD, 47 from OPD to LPD). In the modified intention-to-treat analysis (297 patients in the LPD group and 297 patients in the OPD group), the postoperative length of stay was significantly shorter for patients in the LPD group than for patients in the OPD group (median 15·0 days [95% CI 14·0-16·0] vs 16·0 days [15·0-17·0]; p=0·02). 90-day mortality was similar in both groups (five [2%] of 297 patients in the LPD group vs six [2%] of 297 in the OPD group, risk ratio [RR] 0·83 [95% CI 0·26-2·70]; p=0·76). The incidence rate of serious postoperative morbidities (Clavien-Dindo grade of at least 3) was not significantly different in the two groups (85 [29%] of 297 patients in the LPD group vs 69 [23%] of 297 patients in OPD group, RR 1·23 [95% CI 0·94-1·62]; p=0·13). The comprehensive complication index score was not significantly different between the two groups (median score 8·7 [IQR 0·0-26·2] vs 0·0 [0·0-20·9]; p=0·06). INTERPRETATION: In highly experienced hands, LPD is a safe and feasible procedure. It was associated with a shorter length of stay and similar short-term morbidity and mortality rates to OPD. Nonetheless, the clinical benefit of LPD compared with OPD was marginal despite extensive procedural expertise. Future research should focus on identifying the populations that will benefit from LPD. FUNDING: National Natural Science Foundation of China and Tongji Hospital, Huazhong University of Science and Technology, China.
RCT Entities:
BACKGROUND: The benefit and safety of laparoscopic pancreatoduodenectomy (LPD) for the treatment of pancreatic or periampullary tumours remain controversial. Studies have shown that the learning curve plays an important role in LPD, yet there are no randomised studies on LPD after the surgeons have surmounted the learning curve. The aim of this trial was to compare the outcomes of open pancreatoduodenectomy (OPD) with those of LPD, when performed by experienced surgeons. METHODS: In this multicentre, open-label, randomised controlled trial done in 14 Chinese medical centres, we recruited patients aged 18-75 years with a benign, premalignant, or malignant indication for pancreatoduodenectomy. Eligible patients were randomly assigned (1:1) to undergo either LPD or OPD. Randomisation was centralised via a computer-generated system that used a block size of four. The patients and surgeons were unmasked to study group, whereas the data collectors, outcome assessors, and data analysts were masked. LPD and OPD were performed by experienced surgeons who had already done at least 104 LPD operations. The primary outcome was the postoperative length of stay. The criteria for discharge were based on functional recovery, and analyses were done on a modified intention-to-treat basis (ie, including patients who had a pancreatoduodenectomy regardless of whether the operation was the one they were assigned to). This trial is registered with Clinicaltrials.gov, number NCT03138213. FINDINGS: Between May 18, 2018, and Dec 19, 2019, we assessed 762 patients for eligibility, of whom 656 were randomly assigned to either the LPD group (n=328) or the OPD group (n=328). 31 patients in each group were excluded and 80 patients crossed over (33 from LPD to OPD, 47 from OPD to LPD). In the modified intention-to-treat analysis (297 patients in the LPD group and 297 patients in the OPD group), the postoperative length of stay was significantly shorter for patients in the LPD group than for patients in the OPD group (median 15·0 days [95% CI 14·0-16·0] vs 16·0 days [15·0-17·0]; p=0·02). 90-day mortality was similar in both groups (five [2%] of 297 patients in the LPD group vs six [2%] of 297 in the OPD group, risk ratio [RR] 0·83 [95% CI 0·26-2·70]; p=0·76). The incidence rate of serious postoperative morbidities (Clavien-Dindo grade of at least 3) was not significantly different in the two groups (85 [29%] of 297 patients in the LPD group vs 69 [23%] of 297 patients in OPD group, RR 1·23 [95% CI 0·94-1·62]; p=0·13). The comprehensive complication index score was not significantly different between the two groups (median score 8·7 [IQR 0·0-26·2] vs 0·0 [0·0-20·9]; p=0·06). INTERPRETATION: In highly experienced hands, LPD is a safe and feasible procedure. It was associated with a shorter length of stay and similar short-term morbidity and mortality rates to OPD. Nonetheless, the clinical benefit of LPD compared with OPD was marginal despite extensive procedural expertise. Future research should focus on identifying the populations that will benefit from LPD. FUNDING: National Natural Science Foundation of China and Tongji Hospital, Huazhong University of Science and Technology, China.
Authors: Eliza W Beal; Djhenne Dalmacy; Alessandro Paro; J Madison Hyer; Jordan Cloyd; Mary Dillhoff; Aslam Ejaz; Timothy M Pawlik Journal: J Gastrointest Surg Date: 2022-06-15 Impact factor: 3.267
Authors: Patricia C Conroy; Lucia Calthorpe; Joseph A Lin; Sarah Mohamedaly; Alex Kim; Kenzo Hirose; Eric Nakakura; Carlos Corvera; Julie Ann Sosa; Ankit Sarin; Kimberly S Kirkwood; Adnan Alseidi; Mohamed A Adam Journal: Ann Surg Oncol Date: 2021-11-01 Impact factor: 4.339