- An open-label, randomized trial shows no difference between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) with respect to mortality or complications in stage I gastric cancer.
Why this matters
- Laparoscopic total gastrectomy has been widely adopted, but its safety had not been proven in a randomized trial.
- Prospective, randomized, open-label noninferiority trail of LTG or OTG (N=214).
- Funding: Clinical Trial Fund of Zhongshan Hospital; Johnson & Johnson Medical Ltd.
- Overall morbidity and mortality rates were similar between the 2 groups:
- 19.1% LTG vs 20.2% OTG.
- Rate difference, −1.1% (95% CI, −11.8% to 9.6%).
- Intraoperative complication rate was similar:
- 2.9% LTG vs 3.7% OTG.
- Rate difference, −0.8% (95% CI, −6.5% to 4.9%).
- The overall postoperative complication rate was also similar:
- 18.1% LTG vs 17.4% OTG.
- Rate difference, 0.7% (95% CI, −9.6% to 11.0%).
- Mortality was similar: rate difference, 1.0% (95% CI, −2.5% to 5.2%).
- There was a higher rate of severe complications in the LTG group according to the Clavien-Dindo classification system, but this did not reach statistical significance (7.6% vs 3.8%; P=.52).
- The difference may have resulted from surgeon inexperience.
- Open label.