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J Gastric Cancer. 2019 Mar;19(1):102-110. English. Clinical Trial. https://doi.org/10.5230/jgc.2019.19.e6
Ahn SH , Kang SH , Lee Y , Min SH , Park YS , Park DJ , Kim HH .
Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea. hhkim@snubh.org
Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
Abstract

Purpose

Despite an increased acceptance of laparoscopic gastrectomy (LG) in early gastric cancer (EGC), there is insufficient evidence for its oncological safety in advanced gastric cancer (AGC). This is a prospective phase II clinical trial to evaluate the feasibility of LG with D2 lymph node dissection (LND) in AGC.

Materials and Methods

The primary endpoint was set as 3-year disease-free survival (DFS). The eligibility criteria were as follows: 20-80 years of age, cT2N0-cT4aN3, American Society of Anesthesiologists score of 3 or less, and no other malignancy. Patients were enrolled in this single-arm study between November 2008 and May 2012. Exclusion criteria included cT4b or M1, or having final pathologic results as EGC. All patients underwent D2 lymphadenectomy. Three-year DFS rates were estimated by the Kaplan-Meier method.

Results

A total of 157 patients were enrolled. The overall local complication rate was 10.2%. Conversion to open surgery occurred in 11 patients (7.0%). The mean follow-up period was 55.0±20.4 months (1–81 months). The cumulative 3-year DFS rates were 76.3% for all stages, and 100%, 89.3%, 100%, 88.0%, 71.4%, and 35.3% for stage IB, IIA, IIB, IIIA, IIIB, and IIIC, respectively. Recurrence was observed in 37 patients (23.6%), including hematogenous (n=6), peritoneal (n=13), locoregional (n=1), distant node (n=8), and mixed recurrence (n=9).

Conclusions

In addition to being technically feasible for treatment of AGC in terms of morbidity, LG with D2 LND for locally advanced gastric cancer showed acceptable 3-year DFS outcomes.

Trial Registration

ClinicalTrials.gov Identifier: NCT01441336

Copyright © 2019. Korean Association of Medical Journal Editors.