Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer: A Randomized Clinical Trial

Young Woo Kim; Jae Seok Min; Hong Man Yoon; Ji Yeong An; Bang Wool Eom; Hoon Hur; Young Joon Lee; Gyu Seok Cho; Young Kyu Park; Mi Ran Jung; Ji Ho Park; Woo Jin Hyung; Sang Ho Jeong; Myeong Cherl Kook; Mira Han; Byung Ho Nam; Keun Won Ryu

doi:10.1200/JCO.21.02242

Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer: A Randomized Clinical Trial

Young Woo Kim, Jae Seok Min, Hong Man Yoon, Ji Yeong An, Bang Wool Eom, Hoon Hur, Young Joon Lee, Gyu Seok Cho, Young Kyu Park, Mi Ran Jung, Ji Ho Park, Woo Jin Hyung, Sang Ho Jeong, Myeong Cherl Kook, Mira Han, Byung Ho Nam, Keun Won Ryu

Department of Surgery

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

PURPOSETo compare postoperative complications, long-term survival, and quality of life (QOL) after laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG).METHODSFive hundred eighty patients with preoperatively diagnosed stage IA gastric adenocarcinoma (≤ 3 cm) were assigned to undergo either LSG or LSNNS. Observers were not blinded to patient grouping. The primary outcome was 3-year disease-free survival (3y-DFS). Secondary outcomes included postoperative complications, QOL, 3-year disease-specific survival (3y-DSS), and 3-year overall survival (3y-OS).RESULTSIn total, 527 patients were included in the modified intention-to-treat analysis population for the primary outcome (LSG, 269; LSNNS, 258). Stomach-preserving surgery was performed in 210 patients (81%) in the LSNNS group. During the median follow-up duration, the 3y-DFS rates in the LSG and LSNNS groups were 95.5% and 91.8%, respectively (difference: 3.7%; 95% CI, -0.6 to 8.1). Three patients with recurrence and five with metachronous gastric cancer in the LSNNS group underwent standard surgery. Two patients with distant metastasis in both groups were treated with palliative chemotherapy. The 3y-DSS and 3y-OS rates in the LSG and LSNNS groups were 99.5% and 99.1% (P =.59) and 99.2% and 97.6% (P =.17), respectively. Postoperative complications occurred in 19.0% of the LSG group and 15.5% of the LSNNS group (P =.294). The LSNNS group showed better physical function (P =.015), less symptoms (P <.001), and improved nutrition than the LSG group.CONCLUSIONLSNNS did not show noninferiority to LSG for 3y-DFS, with a 5% margin. However, the 3y-DSS and 3y-OS were not different after rescue surgery in cases of recurrence/metachronous gastric cancer, and LSNNS had better long-term QOL and nutrition than LSG.

Original language	English
Pages (from-to)	2342-2351
Number of pages	10
Journal	Journal of Clinical Oncology
Volume	40
Issue number	21
DOIs	https://doi.org/10.1200/JCO.21.02242
Publication status	Published - 2022

Bibliographical note

Funding Information:
The study design was finalized after discussion with all coinvestigators, and the study was supported by a grant from the National Cancer Center, Korea. All participating coinvestigators enrolled patients, performed surgery, and collected and analyzed data. All authors assert that all procedures and data collection and analysis strictly followed the study protocols. This article was drafted by the last author in consultation with all other authors, and all authors agreed to submit the article for publication. This trial was registered at ClinicalTrials.gov on March 5, 2013 (ClinicalTrials.gov identifier: NCT01804998 ). The first patient was enrolled on March 27, 2013.

Funding Information:
Supported by the National Cancer Center, Republic of Korea (grant numbers 1110550, 1410140, 1710160, and 2010150).

Publisher Copyright:
© American Society of Clinical Oncology.

All Science Journal Classification (ASJC) codes

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1200/JCO.21.02242

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Kim, Y. W., Min, J. S., Yoon, H. M., An, J. Y., Eom, B. W., Hur, H., Lee, Y. J., Cho, G. S., Park, Y. K., Jung, M. R., Park, J. H., Hyung, W. J., Jeong, S. H., Kook, M. C., Han, M., Nam, B. H., & Ryu, K. W. (2022). Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer: A Randomized Clinical Trial. Journal of Clinical Oncology, 40(21), 2342-2351. https://doi.org/10.1200/JCO.21.02242

@article{b632e14068f140eeb75a505db4baf2cc,

title = "Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer: A Randomized Clinical Trial",

abstract = "PURPOSETo compare postoperative complications, long-term survival, and quality of life (QOL) after laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG).METHODSFive hundred eighty patients with preoperatively diagnosed stage IA gastric adenocarcinoma (≤ 3 cm) were assigned to undergo either LSG or LSNNS. Observers were not blinded to patient grouping. The primary outcome was 3-year disease-free survival (3y-DFS). Secondary outcomes included postoperative complications, QOL, 3-year disease-specific survival (3y-DSS), and 3-year overall survival (3y-OS).RESULTSIn total, 527 patients were included in the modified intention-to-treat analysis population for the primary outcome (LSG, 269; LSNNS, 258). Stomach-preserving surgery was performed in 210 patients (81%) in the LSNNS group. During the median follow-up duration, the 3y-DFS rates in the LSG and LSNNS groups were 95.5% and 91.8%, respectively (difference: 3.7%; 95% CI, -0.6 to 8.1). Three patients with recurrence and five with metachronous gastric cancer in the LSNNS group underwent standard surgery. Two patients with distant metastasis in both groups were treated with palliative chemotherapy. The 3y-DSS and 3y-OS rates in the LSG and LSNNS groups were 99.5% and 99.1% (P =.59) and 99.2% and 97.6% (P =.17), respectively. Postoperative complications occurred in 19.0% of the LSG group and 15.5% of the LSNNS group (P =.294). The LSNNS group showed better physical function (P =.015), less symptoms (P <.001), and improved nutrition than the LSG group.CONCLUSIONLSNNS did not show noninferiority to LSG for 3y-DFS, with a 5% margin. However, the 3y-DSS and 3y-OS were not different after rescue surgery in cases of recurrence/metachronous gastric cancer, and LSNNS had better long-term QOL and nutrition than LSG.",

author = "Kim, {Young Woo} and Min, {Jae Seok} and Yoon, {Hong Man} and An, {Ji Yeong} and Eom, {Bang Wool} and Hoon Hur and Lee, {Young Joon} and Cho, {Gyu Seok} and Park, {Young Kyu} and Jung, {Mi Ran} and Park, {Ji Ho} and Hyung, {Woo Jin} and Jeong, {Sang Ho} and Kook, {Myeong Cherl} and Mira Han and Nam, {Byung Ho} and Ryu, {Keun Won}",

note = "Funding Information: The study design was finalized after discussion with all coinvestigators, and the study was supported by a grant from the National Cancer Center, Korea. All participating coinvestigators enrolled patients, performed surgery, and collected and analyzed data. All authors assert that all procedures and data collection and analysis strictly followed the study protocols. This article was drafted by the last author in consultation with all other authors, and all authors agreed to submit the article for publication. This trial was registered at ClinicalTrials.gov on March 5, 2013 (ClinicalTrials.gov identifier: NCT01804998 ). The first patient was enrolled on March 27, 2013. Funding Information: Supported by the National Cancer Center, Republic of Korea (grant numbers 1110550, 1410140, 1710160, and 2010150). Publisher Copyright: {\textcopyright} American Society of Clinical Oncology.",

year = "2022",

doi = "10.1200/JCO.21.02242",

language = "English",

volume = "40",

pages = "2342--2351",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "21",

}

Kim, YW, Min, JS, Yoon, HM, An, JY, Eom, BW, Hur, H, Lee, YJ, Cho, GS, Park, YK, Jung, MR, Park, JH, Hyung, WJ, Jeong, SH, Kook, MC, Han, M, Nam, BH & Ryu, KW 2022, 'Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer: A Randomized Clinical Trial', Journal of Clinical Oncology, vol. 40, no. 21, pp. 2342-2351. https://doi.org/10.1200/JCO.21.02242

TY - JOUR

T1 - Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer

T2 - A Randomized Clinical Trial

AU - Kim, Young Woo

AU - Min, Jae Seok

AU - Yoon, Hong Man

AU - An, Ji Yeong

AU - Eom, Bang Wool

AU - Hur, Hoon

AU - Lee, Young Joon

AU - Cho, Gyu Seok

AU - Park, Young Kyu

AU - Jung, Mi Ran

AU - Park, Ji Ho

AU - Hyung, Woo Jin

AU - Jeong, Sang Ho

AU - Kook, Myeong Cherl

AU - Han, Mira

AU - Nam, Byung Ho

AU - Ryu, Keun Won

N1 - Funding Information: The study design was finalized after discussion with all coinvestigators, and the study was supported by a grant from the National Cancer Center, Korea. All participating coinvestigators enrolled patients, performed surgery, and collected and analyzed data. All authors assert that all procedures and data collection and analysis strictly followed the study protocols. This article was drafted by the last author in consultation with all other authors, and all authors agreed to submit the article for publication. This trial was registered at ClinicalTrials.gov on March 5, 2013 (ClinicalTrials.gov identifier: NCT01804998 ). The first patient was enrolled on March 27, 2013. Funding Information: Supported by the National Cancer Center, Republic of Korea (grant numbers 1110550, 1410140, 1710160, and 2010150). Publisher Copyright: © American Society of Clinical Oncology.

PY - 2022

Y1 - 2022

N2 - PURPOSETo compare postoperative complications, long-term survival, and quality of life (QOL) after laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG).METHODSFive hundred eighty patients with preoperatively diagnosed stage IA gastric adenocarcinoma (≤ 3 cm) were assigned to undergo either LSG or LSNNS. Observers were not blinded to patient grouping. The primary outcome was 3-year disease-free survival (3y-DFS). Secondary outcomes included postoperative complications, QOL, 3-year disease-specific survival (3y-DSS), and 3-year overall survival (3y-OS).RESULTSIn total, 527 patients were included in the modified intention-to-treat analysis population for the primary outcome (LSG, 269; LSNNS, 258). Stomach-preserving surgery was performed in 210 patients (81%) in the LSNNS group. During the median follow-up duration, the 3y-DFS rates in the LSG and LSNNS groups were 95.5% and 91.8%, respectively (difference: 3.7%; 95% CI, -0.6 to 8.1). Three patients with recurrence and five with metachronous gastric cancer in the LSNNS group underwent standard surgery. Two patients with distant metastasis in both groups were treated with palliative chemotherapy. The 3y-DSS and 3y-OS rates in the LSG and LSNNS groups were 99.5% and 99.1% (P =.59) and 99.2% and 97.6% (P =.17), respectively. Postoperative complications occurred in 19.0% of the LSG group and 15.5% of the LSNNS group (P =.294). The LSNNS group showed better physical function (P =.015), less symptoms (P <.001), and improved nutrition than the LSG group.CONCLUSIONLSNNS did not show noninferiority to LSG for 3y-DFS, with a 5% margin. However, the 3y-DSS and 3y-OS were not different after rescue surgery in cases of recurrence/metachronous gastric cancer, and LSNNS had better long-term QOL and nutrition than LSG.

AB - PURPOSETo compare postoperative complications, long-term survival, and quality of life (QOL) after laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG).METHODSFive hundred eighty patients with preoperatively diagnosed stage IA gastric adenocarcinoma (≤ 3 cm) were assigned to undergo either LSG or LSNNS. Observers were not blinded to patient grouping. The primary outcome was 3-year disease-free survival (3y-DFS). Secondary outcomes included postoperative complications, QOL, 3-year disease-specific survival (3y-DSS), and 3-year overall survival (3y-OS).RESULTSIn total, 527 patients were included in the modified intention-to-treat analysis population for the primary outcome (LSG, 269; LSNNS, 258). Stomach-preserving surgery was performed in 210 patients (81%) in the LSNNS group. During the median follow-up duration, the 3y-DFS rates in the LSG and LSNNS groups were 95.5% and 91.8%, respectively (difference: 3.7%; 95% CI, -0.6 to 8.1). Three patients with recurrence and five with metachronous gastric cancer in the LSNNS group underwent standard surgery. Two patients with distant metastasis in both groups were treated with palliative chemotherapy. The 3y-DSS and 3y-OS rates in the LSG and LSNNS groups were 99.5% and 99.1% (P =.59) and 99.2% and 97.6% (P =.17), respectively. Postoperative complications occurred in 19.0% of the LSG group and 15.5% of the LSNNS group (P =.294). The LSNNS group showed better physical function (P =.015), less symptoms (P <.001), and improved nutrition than the LSG group.CONCLUSIONLSNNS did not show noninferiority to LSG for 3y-DFS, with a 5% margin. However, the 3y-DSS and 3y-OS were not different after rescue surgery in cases of recurrence/metachronous gastric cancer, and LSNNS had better long-term QOL and nutrition than LSG.

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EP - 2351

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

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ER -

Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer: A Randomized Clinical Trial

Abstract

Bibliographical note

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UN SDGs

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