Abstract
BackgroundKLASS (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.MethodsPatients 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.DiscussionThirty-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 registrationThe protocol of KLASS 07 (CKLASS 01) was registered in http://register.clinicaltrials.gov as NCT03393182 (Date of registration: January 2nd, 2018.).
Highlights
IntroductionKLASS (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
Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) 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
Since Kitano et al [1] firstly reported laparoscopy-assisted distal gastrectomy (LADG) with lymphadenectomy in 1994, this procedure has been widely accepted as a treatment option for early gastric cancer
Summary
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. Since Kitano et al [1] firstly reported laparoscopy-assisted distal gastrectomy (LADG) with lymphadenectomy in 1994, this procedure has been widely accepted as a treatment option for early gastric cancer. In Korea, LADG with lymphadenectomy was recognized as a safe and effective treatment modality for early gastric cancer (EGC) in a multi-center trial. Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group has performed a prospective randomized controlled trial to show the clinical effectiveness of laparoscopic gastrectomy for early gastric cancer (Registered in www.clinicaltrials.gov as NCT00452751, KLASS 01) [2]. By April 2015, KLASS group has finished the actuall enrollment for KLASS 02, and many gastric cancer surgeons are waiting for the results of this multi-center study
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