Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. In this randomized clinical trial, three-year disease-free survival rates were similar for patients with locally advanced gastric cancer treated with laparoscopic vs. open distal gastrectomy.

2. Overall survival and cumulative incidence of recurrence rates over the 3-year period did not differ between the two groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown:

Surgery for locally advanced gastric cancer, defined as T2, T3, or T4a tumor lacking metastatic disease or bulky lymph nodes, is technically challenging to perform due to required resection of D2 lymph nodes. While evidence suggests that laparoscopic approaches yield shorter hospital stays and faster recovery, it is unclear if they are as effective as open approaches. In this multicenter clinical trial, three-year disease-free survival rates were similar for patients with locally advanced gastric cancer treated with laparoscopic and open distal gastrectomy. Further, overall survival and cumulative incidence of recurrence rates over the 3-year period did not differ between the two groups.

Overall, the study suggests that laparoscopic distal gastrectomy is non-inferior to open distal gastrectomy in patients with locally advanced gastric cancer. Limitations of the study include non-availability of patient-centered outcomes as well as limited importance to Western settings where a proximal gastrectomy is a more common operation that a distal gastrectomy.

In-Depth [ randomized controlled trial]:

The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS-01) was a noninferiority, open-label, randomized clinical trial that was conducted at 14 hospitals in China and recruited 1056 patients with locally advanced gastric cancer from September 2012 to December 2017. Primary end point was 3-year disease-free survival with a noninferiority margin of -10% between laparoscopic distal gastrectomy and open distal gastrectomy. Secondary end points included 3-year overall survival and recurrence patterns were tested for superiority. The study showed that laparoscopic vs open distal gastrectomy resulted in a 3-year disease-free survival rate of 76.5% and 77.8%, a difference that did not significantly exceed the non-inferiority margin of -10%. Further, three-year overall survival rate was 83.1% and 85.2% (p = 0.28) between laparoscopic distal gastrectomy and open distal gastrectomy. Cumulative incidence of recurrence over a 3-year period were 18.8% and 16.5% (p = 0.35) between laparoscopic distal gastrectomy and open distal gastrectomy.

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