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Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial

INTRODUCTION: Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the...

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Autores principales: Zhang, Hang, Feng, Yechen, Zhao, Junfang, Chen, Rufu, Chen, Xuemin, Yin, Xinmin, Cheng, Wei, Li, Dewei, Li, Jingdong, Huang, Xiaobing, Li, Jing, Liu, Jianhua, Liu, Jun, Liu, Yahui, Tan, Zhijian, Zhao, Wenxing, Huang, Heguang, Li, Deyu, Yu, Yahong, Wang, Min, Qin, Renyi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045091/
https://www.ncbi.nlm.nih.gov/pubmed/32047015
http://dx.doi.org/10.1136/bmjopen-2019-033490
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author Zhang, Hang
Feng, Yechen
Zhao, Junfang
Chen, Rufu
Chen, Xuemin
Yin, Xinmin
Cheng, Wei
Li, Dewei
Li, Jingdong
Huang, Xiaobing
Li, Jing
Liu, Jianhua
Liu, Jun
Liu, Yahui
Tan, Zhijian
Zhao, Wenxing
Huang, Heguang
Li, Deyu
Yu, Yahong
Wang, Min
Qin, Renyi
author_facet Zhang, Hang
Feng, Yechen
Zhao, Junfang
Chen, Rufu
Chen, Xuemin
Yin, Xinmin
Cheng, Wei
Li, Dewei
Li, Jingdong
Huang, Xiaobing
Li, Jing
Liu, Jianhua
Liu, Jun
Liu, Yahui
Tan, Zhijian
Zhao, Wenxing
Huang, Heguang
Li, Deyu
Yu, Yahong
Wang, Min
Qin, Renyi
author_sort Zhang, Hang
collection PubMed
description INTRODUCTION: Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomised controlled trials (RCTs) are lacking but are clearly required. METHODS AND ANALYSIS: TJDBPS01 is a multicentre, prospective, randomised controlled, parallel-group, superiority trial in 14 centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay. ETHICS AND DISSEMINATION: The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organisation. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: NCT03138213
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spelling pubmed-70450912020-03-09 Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial Zhang, Hang Feng, Yechen Zhao, Junfang Chen, Rufu Chen, Xuemin Yin, Xinmin Cheng, Wei Li, Dewei Li, Jingdong Huang, Xiaobing Li, Jing Liu, Jianhua Liu, Jun Liu, Yahui Tan, Zhijian Zhao, Wenxing Huang, Heguang Li, Deyu Yu, Yahong Wang, Min Qin, Renyi BMJ Open Gastroenterology and Hepatology INTRODUCTION: Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomised controlled trials (RCTs) are lacking but are clearly required. METHODS AND ANALYSIS: TJDBPS01 is a multicentre, prospective, randomised controlled, parallel-group, superiority trial in 14 centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay. ETHICS AND DISSEMINATION: The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organisation. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: NCT03138213 BMJ Publishing Group 2020-02-10 /pmc/articles/PMC7045091/ /pubmed/32047015 http://dx.doi.org/10.1136/bmjopen-2019-033490 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Gastroenterology and Hepatology
Zhang, Hang
Feng, Yechen
Zhao, Junfang
Chen, Rufu
Chen, Xuemin
Yin, Xinmin
Cheng, Wei
Li, Dewei
Li, Jingdong
Huang, Xiaobing
Li, Jing
Liu, Jianhua
Liu, Jun
Liu, Yahui
Tan, Zhijian
Zhao, Wenxing
Huang, Heguang
Li, Deyu
Yu, Yahong
Wang, Min
Qin, Renyi
Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial
title Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial
title_full Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial
title_fullStr Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial
title_full_unstemmed Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial
title_short Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial
title_sort total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (tjdbps01): study protocol for a multicentre, randomised controlled clinical trial
topic Gastroenterology and Hepatology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045091/
https://www.ncbi.nlm.nih.gov/pubmed/32047015
http://dx.doi.org/10.1136/bmjopen-2019-033490
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