Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001).

Abstract

OBJECTIVE:

This randomized, phase II, multicenter clinical trial was conducted to evaluate the feasibility of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection compared with open distal gastrectomy (ODG) for the treatment of advanced gastric cancer (AGC).

SUMMARY OF BACKGROUND DATA:

D2 lymph node dissection has been accepted as standard treatment for AGC. Although LADG is widely performed in early gastric cancer (EGC), the feasibility of LADG in AGC has not been proven yet.

METHODS:

Patients with cT2-T4a and cN0-2 (AJCC 7 staging system) distal gastric cancer were randomly but not blindingly assigned to LADG or ODG groups using fixed block sizes with a 1:1 allocation ratio. The primary endpoint was the noncompliance rate of the lymph node dissection, which was used to evaluate feasibility. Secondary endpoints included 3-year disease-free survival (DFS), 5-year overall survival, complications, and surgical stress response.

RESULTS:

Between June 2010 and October 2011, 204 patients enrolled and underwent either LADG (n = 105) or ODG (n = 99). Of these, 196 patients (100 in LADG and 96 in ODG) were included in the intention-to-treat analysis. There were no significant differences in the overall noncompliance rate of lymph node dissection between LADG and ODG groups (47.0% and 43.2%, respectively; P = 0.648). In the subgroup analysis, the noncompliance rate in the LADG group was significantly higher than the ODG group for clinical stage III disease (52.0% vs 25.0%, P = 0.043). No difference was found in the 3-year DFS rate between the groups (LADG, 80.1%; ODG, 81.9%; P = 0.448). Differences in postoperative complication rates and surgical stress response were found to be insignificant between the 2 arms.

CONCLUSIONS:

LADG was feasible for AGC treatment based on the noncompliance rate of D2 lymph node dissection. Subgroups analysis data suggest that further studies are needed for stage III gastric cancer.

• Authors: Young Kyu Park, Hong Man Yoon, Young-Woo Kim, Ji Yeon Park, Keun Won Ryu, Young-Joon Lee, Oh Jeong, Ki Young Yoon, Jun Ho Lee, Sang Eok Lee, Wansik Yu, Sang-Ho Jeong, Taebong Kim, Sohee Kim, Byoung-Ho Nam, COACT group
• Journal: Annals of surgery (Ann Surg) Vol. 267 Issue 4 Pg. 638-645 (04 2018) ISSN: 1528-1140 [Electronic] United States
• PMID: 28187041 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Adenocarcinoma (pathology, surgery)
• Adult
• Aged
• Aged, 80 and over
• Disease-Free Survival
• Feasibility Studies
• Gastrectomy (adverse effects, methods)
• Guideline Adherence
• Humans
• Intention to Treat Analysis
• Laparoscopy (adverse effects, methods)
• Lymph Node Excision
• Middle Aged
• Neoplasm Staging
• Postoperative Complications
• Prospective Studies
• Stomach Neoplasms (pathology, surgery)
• Stress, Physiological