Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trial
Abstract Background The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02–01) to compare the sa...
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doaj-acbd3c24fa274b399ff95e7a9b6c66832020-11-25T00:47:49ZengBMCBMC Cancer1471-24072018-10-011811610.1186/s12885-018-4846-zStudy on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trialHongyong He0Haojie Li1Xiangqian Su2Ziyu Li3Peiwu Yu4Hua Huang5Changming Huang6Jianxin Ye7Yong Li8Jian Suo9Jiren Yu10Guoxin Li11Zekuan Xu12Gang Zhao13Hui Cao14Jiankun Hu15Xiaohui Du16Fenglin Liu17Yihong Sun18on behalf of the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) GroupDepartment of General Surgery, Zhongshan Hospital, Fudan UniversityDepartment of General Surgery, Zhongshan Hospital, Fudan UniversityDepartment of General Surgery, Beijing Cancer Hospital, Peking UniversityDepartment of General Surgery, Beijing Cancer Hospital, Peking UniversityDepartment of General Surgery, Southwest Hospital, Third Military Medical UniversityDepartment of General Surgery, Fudan University Shanghai Cancer CenterDepartment of General Surgery, Fujian Medical University Union HospitalDepartment of General Surgery, The First Affiliated Hospital of Fujian Medical UniversityDepartment of General Surgery, Guangdong General HospitalDepartment of General Surgery, The First Bethune Hospital of Jilin UniversityDepartment of General Surgery, The First Affiliated Hospital, Zhejiang UniversityDepartment of General Surgery, Nangfang Hospital, Southern Medical UniversityDepartment of General Surgery, The First Affiliated Hospital With Nanjing Medical UniversityDepartment of General Surgery, Renji Hospital, Shanghai Jiaotong UniversityDepartment of General Surgery, Renji Hospital, Shanghai Jiaotong UniversityDepartment of General Surgery, West China Hospital, Sichuan UniversityDepartment of General Surgery, Chinese PLA General HospitalDepartment of General Surgery, Zhongshan Hospital, Fudan UniversityDepartment of General Surgery, Zhongshan Hospital, Fudan UniversityAbstract Background The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02–01) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG). Methods This CLASS02–01 trial is a prospective, multicenter, randomized, controlled, open, and non-inferiority trial. Two hundred patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into LTG group (n = 100) and OTG group (n = 100). The primary purpose of this study is to evaluate the early operative morbidity and mortality of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study. Discussion This CLASS02–01 trial is the first prospective randomized two-arm controlled study to determine the safety of LTG compared with OTG. Through this trial, we hope to show that experienced surgeons can safely perform LTG with lymphadenectomy for gastric cancer. Trial registration ClinicalTrials.gov ID: NCT03007550. December 30, 2016.http://link.springer.com/article/10.1186/s12885-018-4846-zGastric cancerLaparoscopic total gastrectomySafetyRandomized controlled trial |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Hongyong He Haojie Li Xiangqian Su Ziyu Li Peiwu Yu Hua Huang Changming Huang Jianxin Ye Yong Li Jian Suo Jiren Yu Guoxin Li Zekuan Xu Gang Zhao Hui Cao Jiankun Hu Xiaohui Du Fenglin Liu Yihong Sun on behalf of the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group |
spellingShingle |
Hongyong He Haojie Li Xiangqian Su Ziyu Li Peiwu Yu Hua Huang Changming Huang Jianxin Ye Yong Li Jian Suo Jiren Yu Guoxin Li Zekuan Xu Gang Zhao Hui Cao Jiankun Hu Xiaohui Du Fenglin Liu Yihong Sun on behalf of the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trial BMC Cancer Gastric cancer Laparoscopic total gastrectomy Safety Randomized controlled trial |
author_facet |
Hongyong He Haojie Li Xiangqian Su Ziyu Li Peiwu Yu Hua Huang Changming Huang Jianxin Ye Yong Li Jian Suo Jiren Yu Guoxin Li Zekuan Xu Gang Zhao Hui Cao Jiankun Hu Xiaohui Du Fenglin Liu Yihong Sun on behalf of the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group |
author_sort |
Hongyong He |
title |
Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trial |
title_short |
Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trial |
title_full |
Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trial |
title_fullStr |
Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trial |
title_full_unstemmed |
Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02–01 multicenter randomized controlled clinical trial |
title_sort |
study on safety of laparoscopic total gastrectomy for clinical stage i gastric cancer: the protocol of the class02–01 multicenter randomized controlled clinical trial |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2018-10-01 |
description |
Abstract Background The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02–01) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG). Methods This CLASS02–01 trial is a prospective, multicenter, randomized, controlled, open, and non-inferiority trial. Two hundred patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into LTG group (n = 100) and OTG group (n = 100). The primary purpose of this study is to evaluate the early operative morbidity and mortality of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study. Discussion This CLASS02–01 trial is the first prospective randomized two-arm controlled study to determine the safety of LTG compared with OTG. Through this trial, we hope to show that experienced surgeons can safely perform LTG with lymphadenectomy for gastric cancer. Trial registration ClinicalTrials.gov ID: NCT03007550. December 30, 2016. |
topic |
Gastric cancer Laparoscopic total gastrectomy Safety Randomized controlled trial |
url |
http://link.springer.com/article/10.1186/s12885-018-4846-z |
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