Abstract
BackgroundThe 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).MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov ID: NCT03007550. December 30, 2016.
Highlights
The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence
The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with open total gastrectomy (OTG) for clinical stage I gastric adenocarcinoma
For gastric cancer located on the proximal side of the stomach, both proximal gastrectomy (PG) and total gastrectomy (TG) can be considered, and each has advantages and disadvantages [16]
Summary
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). More than 20 years after the introduction of laparoscopic gastrectomy, many large-scale randomized controlled trials (RCT) have been conducted in Japan (JCOG0912 and JLSSG0901) [3, 4], Korea (KLASS01 and KLASS02) [5–9], and China (CLASS01) [10]. China is one of the countries with the highest incidence of gastric cancer and surgeons have accumulated extensive experience through CLASS01 study. It’s time for conducting the clinical research on the safety of LTG for gastric cancer
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