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 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.

Keywords: Gastric cancer; Laparoscopic total gastrectomy; Randomized controlled trial; Safety.

Conflict of interest statement

Ethics approval and consent to participate

Before enrollment of first patient, this study was approved from the institutional review boards of all research centers (14 tertiary hospitals) in China, including Zhongshan Hospital Fudan University (B2016-160R), Beijing Cancer Hospital, Southwest Hospital, Fudan University Shanghai Cancer Center, Fujian Medical University Union Hospital, The First Affiliated Hospital of Fujian Medical University, Guangdong General Hospital, The First Bethune Hospital of Jilin University, The First Affiliated Hospital Zhejiang University, Nangfang Hospital, The First Affiliated Hospital With Nanjing Medical University, Renji Hospital, West China Hospital, Sichuan University, and Chinese PLA General Hospital. Written informed consent will be obtained from all patients for the acquisition and use of anonymized clinical data before they are recruited.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Study schema