@article{6d354c3145d74e258827e12578c6f3db,
title = "A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol)",
abstract = "Background: KLASS (the Korean Laparoendoscopic Gastrointestinal Surgery Study) is a time-honored study group that has established laparoscopic surgery for gastrointestinal disease in Korea and has performed some important studies for the rationale of laparoscopic gastrointestinal surgery. A multi-center RCT (randomized controlled trial) to compare the quality of life (QOL) of patients undergoing totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer, named as KLASS 07, has been currently prepared in Korea. Methods: Patients diagnosed as gastric cancer, with clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the Americal Joint Committee on Cancer System, were randomized to receive either TLDG or LADG. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 gastrectomies and at least 30 gastrectomies annually (regardless of open or laparoscopic surgery for gastric cancer). The patients who are allocated to TLDG group undergo intracorporeal anastomosis and those who are assigned to LADG undergo extracorporeal anastomosis for gastrointestinal reconstruction. Discussion: Thirty-one surgeons from 26 institutions were engaged in this trial. The primary endpoint is 30-day morbidity, and secondary endpoint is QOL assessed by the questionnaire score. The KLASS 07 trial is the first multi-center RCT to investigate whether there are significant and quantifiable differences between the QOL of TLDG and LADG. The findings from this trial are expected to be the critical clues for designing the detailed procedures during laparoscopic surgery for gastric cancer. Trial registration: The protocol of KLASS 07 (CKLASS 01) was registered in http://register.clinicaltrials.gov as NCT03393182 (Date of registration: January 2nd, 2018.).",
keywords = "Gastric cancer, Laparoscopy-assisted distal gastrectomy, Randomized controlled trial, Totally laparoscopic distal gastrectomy",
author = "Lee, {Chang Min} and Park, {Ji Ho} and {In Choi}, Chang and Lee, {Han Hong} and Min, {Jae Seok} and Jee, {Ye Seob} and Oh Jeong and Hyundong Chae and Choi, {Sung Il} and Hua Huang and Sungsoo Park",
note = "Funding Information: KLASS-07 group: Hoon Hur (Ajou University School of Medicine), Moon-Won Yoo (University of Ulsan College of Medicine), Kyo Young Song (College of Medicine, The Catholic University of Korea), Han Hong Lee (College of Medicine, The Catholic University of Korea), Chang Hyun Kim (College of Medicine, The Catholic University of Korea), Chan Young Kim (Chonbuk National University Medical School), Oh Jeong (Chonnam National University Medical School), Ho Goon Kim (Chonnam National University Medical School), Hyundong Chae (Catholic University of Daegu School of Medicine), Moon-Soo Lee (Eulji University School of Medicine), Ye Seob Jee (Dankook University College of Medicine), Jae-Seok Min (Dongnam Institute of Radiological and Medical Science), Sung Jin Oh (Inje University College of Medicine), Sang Hyuk Seo (Inje University College of Medicine), In Ho Jeong (Jeju National University School of Medicine), Sungsoo Kim (School of Medicine, Chosun University), Seungwan Ryu (Keimyung University School of Medicine), Sang Eok Lee (Konyang University College of Medicine), Sungsoo Park (Korea University College of Medicine), Jong-Han Kim (Korea University College of Medicine), Chang Min Lee (Korea University College of Medicine), Sung IL Choi (Kyung Hee University Hospital at Gangdong), Chang In Choi (Pusan National Universtiy Hospital), Sun-Hwi Hwang (Pusan National University Yangsan Hospital). The Chinese co-researchers of CKLASS-01 group: Ziyu LI (Peking University Cancer Hospital & Institute, Beijing), Hua Huang (Fudan University Shanghai Cancer Center), Xuefei Wang (Zhongshan Hospital Fudan University), Weidong Zang (Fujian Medical University Cancer Hospital), Wei Wang (Guangdong General Hospital, Guangdong Academy of Medical Sciences), Yong Li, (Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences), Kuang Wang (Harbin Medical University Cancer Hospital), Qing Qiao (The Fourth Military Medical University Tangdu Hospital), Gang JI (The Fourth Military Medical University, Xijing Hospital),Yongliang Zhao (The First Hospital Affiliated to AMU), Zhengrong Li (The First Affiliated Hospital of Nanchang University), Jiang Yu (Nanfang Hospital, Southern Medical University), Li Yang (The First Affiliated Hospital of Nanjing Medical University), Zhaojian Niu (The Affiliated Hospital of Qingdao University), Su Yan (Qinghai University Affiliated Hospital), Changqing Jing (Shandong Provincial Hospital Affiliated to Shandong University), Lu Zang (Ruijin Hospital, Shanghai Jiaotong University School of Medicine), Lin Fan (The First Affiliated Hospital of Xi{\textquoteright}an Jiaotong University), Gaoping Zhao (Sichuan Provincial People{\textquoteright}s Hospital), Jun You (First Affiliated Hospital of Xiamen University), Linhua Zhu (Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University), Yian Du (Zhejiang Cancer Hospital), Xiao hui Du (Chinese People{\textquoteright}s Liberation Army General Hospital), Yan tao Tian (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College), Wu Song (The First Affiliated Hospital of Sun Yat-sen University).",
year = "2019",
month = mar,
day = "7",
doi = "10.1186/s12885-019-5396-8",
language = "English",
volume = "19",
journal = "BMC Cancer",
issn = "1471-2407",
publisher = "BioMed Central",
number = "1",
}