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Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301)

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Abstract

Background

The purpose of this study was to evaluate laparoscopy-assisted distal gastrectomy (LADG) compared to open distal gastrectomy (ODG) in the treatment of early gastric cancer with respect to survival, surgical outcomes, complications, and quality of life (QOL).

Methods

One hundred sixty-four patients with cT1N0M0 and cT1N1M0 distal gastric cancer were randomly assigned to either the LADG group or the ODG group. The primary end point was the 5-year disease-free survival (DFS) rate. Complications were classified using the accordion severity classification of postoperative complications scheme. QOL was measured using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-STO22 preoperatively and postoperatively during regular follow-up visits. This trial is registered at ClinicalTrials.gov (NCT00546468).

Results

The median (range) follow-up period was 74.3 (24.8–90.8) months. The LADG and ODG groups showed similar survival [5-year DFS rate: 98.8 % vs. 97.6 %, respectively (P = 0.514), 5-year overall survival (OS) rate: 97.6 vs. 96.3 %, respectively (P = 0.721)] or overall complication rate (29.3 vs. 42.7 %, respectively; P = 0.073). Mild complications were significantly less frequent in the LADG group than in the ODG group (23.2 vs. 41.5 %; P = 0.012). The rates of moderate, severe, and long-term complications (i.e., 31 days to 5 years after surgery) did not differ significantly between groups. No clinically meaningful differences were detected between the two groups in long-term QOL.

Conclusion

LADG showed similar DFS and OS compared to ODG in treating early gastric cancer. Marginal benefits in mild complications were observed with LADG. LADG did not show advantages over ODG regarding other complications and long-term QOL.

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Acknowledgments

This work was supported by a Grant (NCC 0310060-1,2,3) from the National Cancer Center, South Korea. We thank Jae Gahb Park, MD, Jin Soo Lee, MD, Jae-Moon Bae, MD, Seung Hoon Lee, MD, previous and present staff members of the Center for Gastric Cancer (Myeong-Cherl Kook, MD, Jong Seok Lee, MD, Sang-Gyun Kim, MD, Ho Joon Song, MD, Il Ju Choi, MD, Chan Gyu Kim, MD, Jong Yeul Lee, M.D., Soo Jeong Cho, MD, Ji Yoon Rho, M.D.), scrub nurses in the operating room, and nurses in the ward for their support during this clinical study. We also thank Hyun-Jung Park, RN, Eun Ju Yoo, RN, Yura Kim, RN, Seonhui Park, RN, Seonmi Kim, RN, Jaehyeun Lee, RN, Iyeong Kim, RN, Miae Park, RN, and Jiyeong Jang, RN, for collecting the data.

Disclosures

Young-Woo Kim, Hong Man Yoon, Young Ho Yun, Byung Ho Nam, Bang Wool Eom, Yong Hae Baik, Sang Eok Lee, Yeji Lee, Young-ae Kim, Ji Yeon Park, and Keun Won Ryu have no conflicts of interest or financial ties to disclose.

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Correspondence to Young-Woo Kim or Young Ho Yun.

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Young-Woo Kim and Hong Man Yoon contributed equally to this study.

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Kim, YW., Yoon, H.M., Yun, Y.H. et al. Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301). Surg Endosc 27, 4267–4276 (2013). https://doi.org/10.1007/s00464-013-3037-x

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