Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial

Abstract

BackgroundDespite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial.Methods/designThis trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial.DiscussionThis clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure.Trial registrationClinicalTrial.gov, NCT01456598.

The current state of stomach cancer surgery in the world

“…Analysis of the final survival data are expected by the end of 2016. Subsequently, they conducted KLASS-02, another open versus laparoscopy Phase III trial for clinically T2∼T4a gastric cancer, resectable by distal gastrectomy, with 3-year relapse-free survival as the primary endpoint (44). This is also a large-scale trial with a sample size of 1050, but the patient recruitment was prompt and has already terminated in 2015.…”

Minimally invasive surgery for gastric cancer: the American experience

“…Over the last 20 years, the safety and oncologic efficacy of laparoscopic gastrectomy has been studied, perhaps most notably by the Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group and the Japanese Laparoscopic Surgery Study Group (JLSSG) [3][4][5][6]. The recent implementation of robotic technology has further added to the armamentarium of surgical oncologists, providing a corresponding ease with which surgical dissections are performed [7][8][9].…”

Ongoing surgical clinical trials on minimally invasive surgery for gastric cancer: Korea

“…Six unedited videos of LDG and ODG were submitted by surgeons for participation and reviewed by international experts using evaluation criteria for completeness of D2 lymphadenectomy. Finally, the review committee made decisions on whether a surgeon's qualification was sufficient to participate in KLASS-02-RCT (16). The primary endpoint of the KLASS-02 RCT is non-inferiority in the 3-year relapse-free survival rate after LDG and D2 lymphadenectomy for locally AGC compared with open conventional surgery.…”