A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03

WooJin Hyung, Han Kwang Yang, Sang Uk Han, Young Jun Lee, Joong Min Park, Jin Jo Kim, Oh Kyung Kwon, Seong Ho Kong, Hyoung Il Kim, Hyuk Joon Lee, Wook Kim, Seung Wan Ryu, Sung Ho Jin, Sung Jin Oh, Keun Won Ryu, Min Chan Kim, Hye Seong Ahn, Young Kyu Park, Young Ho Kim, Sun Hwi Hwang & 2 others Jong Won Kim, Gyu Seok Cho

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Abstract

Background: With improved short-term surgical outcomes, laparoscopic distal gastrectomy has rapidly gained popularity. However, the safety and feasibility of laparoscopic total gastrectomy (LTG) has not yet been proven due to the difficulty of the technique. This single-arm prospective multi-center study was conducted to evaluate the use of LTG for clinical stage I gastric cancer. Methods: Between October 2012 and January 2014, 170 patients with pathologically proven, clinical stage I gastric adenocarcinoma located at the proximal stomach were enrolled. Twenty-two experienced surgeons from 19 institutions participated in this clinical trial. The primary end point was the incidence of postoperative morbidity and mortality at postoperative 30 days. The severity of postoperative complications was categorized according to Clavien–Dindo classification, and the incidence of postoperative morbidity and mortality was compared with that in a historical control. Results: Of the enrolled patients, 160 met criteria for inclusion in the full analysis set. Postoperative morbidity and mortality rates reached 20.6% (33/160) and 0.6% (1/160), respectively. Fifteen patients (9.4%) had grade III or higher complications, and three reoperations (1.9%) were performed. The incidence of morbidity after LTG in this trial did not significantly differ from that reported in a previous study for open total gastrectomy (18%). Conclusions: LTG performed by experienced surgeons showed acceptable postoperative morbidity and mortality for patients with clinical stage I gastric cancer.

LanguageEnglish
Pages214-222
Number of pages9
JournalGastric Cancer
Volume22
Issue number1
DOIs
Publication statusPublished - 2019 Jan 22

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Phase II Clinical Trials
Feasibility Studies
Gastrectomy
Stomach Neoplasms
Morbidity
Mortality
Incidence
Stomach
Reoperation
Adenocarcinoma
Clinical Trials
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

Hyung, WooJin ; Yang, Han Kwang ; Han, Sang Uk ; Lee, Young Jun ; Park, Joong Min ; Kim, Jin Jo ; Kwon, Oh Kyung ; Kong, Seong Ho ; Kim, Hyoung Il ; Lee, Hyuk Joon ; Kim, Wook ; Ryu, Seung Wan ; Jin, Sung Ho ; Oh, Sung Jin ; Ryu, Keun Won ; Kim, Min Chan ; Ahn, Hye Seong ; Park, Young Kyu ; Kim, Young Ho ; Hwang, Sun Hwi ; Kim, Jong Won ; Cho, Gyu Seok. / A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer : a prospective multi-center phase II clinical trial, KLASS 03. In: Gastric Cancer. 2019 ; Vol. 22, No. 1. pp. 214-222.
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title = "A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03",
abstract = "Background: With improved short-term surgical outcomes, laparoscopic distal gastrectomy has rapidly gained popularity. However, the safety and feasibility of laparoscopic total gastrectomy (LTG) has not yet been proven due to the difficulty of the technique. This single-arm prospective multi-center study was conducted to evaluate the use of LTG for clinical stage I gastric cancer. Methods: Between October 2012 and January 2014, 170 patients with pathologically proven, clinical stage I gastric adenocarcinoma located at the proximal stomach were enrolled. Twenty-two experienced surgeons from 19 institutions participated in this clinical trial. The primary end point was the incidence of postoperative morbidity and mortality at postoperative 30 days. The severity of postoperative complications was categorized according to Clavien–Dindo classification, and the incidence of postoperative morbidity and mortality was compared with that in a historical control. Results: Of the enrolled patients, 160 met criteria for inclusion in the full analysis set. Postoperative morbidity and mortality rates reached 20.6{\%} (33/160) and 0.6{\%} (1/160), respectively. Fifteen patients (9.4{\%}) had grade III or higher complications, and three reoperations (1.9{\%}) were performed. The incidence of morbidity after LTG in this trial did not significantly differ from that reported in a previous study for open total gastrectomy (18{\%}). Conclusions: LTG performed by experienced surgeons showed acceptable postoperative morbidity and mortality for patients with clinical stage I gastric cancer.",
author = "WooJin Hyung and Yang, {Han Kwang} and Han, {Sang Uk} and Lee, {Young Jun} and Park, {Joong Min} and Kim, {Jin Jo} and Kwon, {Oh Kyung} and Kong, {Seong Ho} and Kim, {Hyoung Il} and Lee, {Hyuk Joon} and Wook Kim and Ryu, {Seung Wan} and Jin, {Sung Ho} and Oh, {Sung Jin} and Ryu, {Keun Won} and Kim, {Min Chan} and Ahn, {Hye Seong} and Park, {Young Kyu} and Kim, {Young Ho} and Hwang, {Sun Hwi} and Kim, {Jong Won} and Cho, {Gyu Seok}",
year = "2019",
month = "1",
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doi = "10.1007/s10120-018-0864-4",
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Hyung, W, Yang, HK, Han, SU, Lee, YJ, Park, JM, Kim, JJ, Kwon, OK, Kong, SH, Kim, HI, Lee, HJ, Kim, W, Ryu, SW, Jin, SH, Oh, SJ, Ryu, KW, Kim, MC, Ahn, HS, Park, YK, Kim, YH, Hwang, SH, Kim, JW & Cho, GS 2019, 'A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03', Gastric Cancer, vol. 22, no. 1, pp. 214-222. https://doi.org/10.1007/s10120-018-0864-4

A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer : a prospective multi-center phase II clinical trial, KLASS 03. / Hyung, WooJin; Yang, Han Kwang; Han, Sang Uk; Lee, Young Jun; Park, Joong Min; Kim, Jin Jo; Kwon, Oh Kyung; Kong, Seong Ho; Kim, Hyoung Il; Lee, Hyuk Joon; Kim, Wook; Ryu, Seung Wan; Jin, Sung Ho; Oh, Sung Jin; Ryu, Keun Won; Kim, Min Chan; Ahn, Hye Seong; Park, Young Kyu; Kim, Young Ho; Hwang, Sun Hwi; Kim, Jong Won; Cho, Gyu Seok.

In: Gastric Cancer, Vol. 22, No. 1, 22.01.2019, p. 214-222.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer

T2 - Gastric Cancer

AU - Hyung, WooJin

AU - Yang, Han Kwang

AU - Han, Sang Uk

AU - Lee, Young Jun

AU - Park, Joong Min

AU - Kim, Jin Jo

AU - Kwon, Oh Kyung

AU - Kong, Seong Ho

AU - Kim, Hyoung Il

AU - Lee, Hyuk Joon

AU - Kim, Wook

AU - Ryu, Seung Wan

AU - Jin, Sung Ho

AU - Oh, Sung Jin

AU - Ryu, Keun Won

AU - Kim, Min Chan

AU - Ahn, Hye Seong

AU - Park, Young Kyu

AU - Kim, Young Ho

AU - Hwang, Sun Hwi

AU - Kim, Jong Won

AU - Cho, Gyu Seok

PY - 2019/1/22

Y1 - 2019/1/22

N2 - Background: With improved short-term surgical outcomes, laparoscopic distal gastrectomy has rapidly gained popularity. However, the safety and feasibility of laparoscopic total gastrectomy (LTG) has not yet been proven due to the difficulty of the technique. This single-arm prospective multi-center study was conducted to evaluate the use of LTG for clinical stage I gastric cancer. Methods: Between October 2012 and January 2014, 170 patients with pathologically proven, clinical stage I gastric adenocarcinoma located at the proximal stomach were enrolled. Twenty-two experienced surgeons from 19 institutions participated in this clinical trial. The primary end point was the incidence of postoperative morbidity and mortality at postoperative 30 days. The severity of postoperative complications was categorized according to Clavien–Dindo classification, and the incidence of postoperative morbidity and mortality was compared with that in a historical control. Results: Of the enrolled patients, 160 met criteria for inclusion in the full analysis set. Postoperative morbidity and mortality rates reached 20.6% (33/160) and 0.6% (1/160), respectively. Fifteen patients (9.4%) had grade III or higher complications, and three reoperations (1.9%) were performed. The incidence of morbidity after LTG in this trial did not significantly differ from that reported in a previous study for open total gastrectomy (18%). Conclusions: LTG performed by experienced surgeons showed acceptable postoperative morbidity and mortality for patients with clinical stage I gastric cancer.

AB - Background: With improved short-term surgical outcomes, laparoscopic distal gastrectomy has rapidly gained popularity. However, the safety and feasibility of laparoscopic total gastrectomy (LTG) has not yet been proven due to the difficulty of the technique. This single-arm prospective multi-center study was conducted to evaluate the use of LTG for clinical stage I gastric cancer. Methods: Between October 2012 and January 2014, 170 patients with pathologically proven, clinical stage I gastric adenocarcinoma located at the proximal stomach were enrolled. Twenty-two experienced surgeons from 19 institutions participated in this clinical trial. The primary end point was the incidence of postoperative morbidity and mortality at postoperative 30 days. The severity of postoperative complications was categorized according to Clavien–Dindo classification, and the incidence of postoperative morbidity and mortality was compared with that in a historical control. Results: Of the enrolled patients, 160 met criteria for inclusion in the full analysis set. Postoperative morbidity and mortality rates reached 20.6% (33/160) and 0.6% (1/160), respectively. Fifteen patients (9.4%) had grade III or higher complications, and three reoperations (1.9%) were performed. The incidence of morbidity after LTG in this trial did not significantly differ from that reported in a previous study for open total gastrectomy (18%). Conclusions: LTG performed by experienced surgeons showed acceptable postoperative morbidity and mortality for patients with clinical stage I gastric cancer.

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U2 - 10.1007/s10120-018-0864-4

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JF - Gastric Cancer

SN - 1436-3291

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