Abstract
BackgroundAlthough laparoscopic surgery has been recommended as an optional therapy for patients with early gastric cancer, whether patients with locally advanced gastric cancer (AGC) could benefit from laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy remains elusive due to a lack of comprehensive clinical data. To evaluate the efficacy of LADG, we conducted a multi-institutional randomized controlled trial to compare laparoscopy-assisted versus open distal gastrectomy (ODG) for AGC in North China.MethodsIn this RCT, after patients were enrolled according to the eligibility criteria, they were preoperatively assigned to LADG or ODG arm randomly with a 1:1 allocation ratio. The primary endpoint was the morbidity and mortality within 30 postoperative days to evaluate the surgical safety of LADG. The secondary endpoint was 3-year disease-free survival. This trial was registered at ClinicalTrial.gov as NCT02464215.ResultsBetween March 2014 and August 2017, a total of 446 patients with cT2-4aN0-3M0 (AJCC 7th staging system) were enrolled. Of these, 222 patients underwent LADG and 220 patients underwent ODG were included in the modified intention-to-treat analysis. The compliance rate of D2 lymph node dissection was identical between the LADG and ODG arms (99.5%, P = 1.000). No significant difference was observed regarding the overall postoperative complication rate in two groups (LADG 13.1%, ODG 17.7%, P = 0.174). No operation-related death occurred in both arms.ConclusionsThis trial confirmed that LADG performed by credentialed surgeons was safe and feasible for patients with AGC compared with conventional ODG.
Highlights
Laparoscopic surgery has been recommended as an optional therapy for patients with early gastric cancer, whether patients with locally advanced gastric cancer (AGC) could benefit from laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy remains elusive due to a lack of comprehensive clinical data
The inclusion criteria for enrolling patients were as follows: Patients age older than 18 years; Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy; Tumor located in the lower part of the stomach, potentially resectable by subtotal gastrectomy and D2 lymph node dissection; Preoperative cancer stage cT2-4aN0-3M0; The Eastern Cooperative Oncology Group performance status of 0 or 1, or the American Society of Anesthesiology classes of I, II, or III; Signed Informed consent
In order to evaluate the surgical safety of LADG, the overall postoperative complication rate was set as the primary endpoint of this trial
Summary
This study was designed as a multicenter, open-label, non-inferiority, parallel, prospective RCT conducted at five high-volume university hospitals with nine surgeons in Beijing, China. The inclusion criteria for enrolling patients were as follows: Patients age older than 18 years (including 18 years old); Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell, and poorly differentiated adenocarcinoma); Tumor located in the lower part of the stomach, potentially resectable by subtotal gastrectomy and D2 lymph node dissection; Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging); The Eastern Cooperative Oncology Group performance status of 0 or 1, or the American Society of Anesthesiology classes of I, II, or III; Signed Informed consent. All surgeons involved in this trial were specialized in gastric surgery, and have already conducted at least 60 ODG and 60 LADG with D2 lymphadenectomy previously. In order to evaluate the surgical safety of LADG, the overall postoperative complication rate was set as the primary endpoint of this trial. The relative risk with 95% confidence interval (CI) for the intraoperative and postoperative complication rates of the LADG group was calculated relative to the reference group. All statistical analyses were conducted with SPSS (Version 20.0 for Windows; SPSS Inc., Chicago, IL)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
