Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)

被引：92

作者：

Kim, Hyung-Ho ^{[1
]}

Han, Sang-Uk ^{[2
]}

Kim, Min-Chan ^{[3
]}

Hyung, Woo Jin ^{[4
]}

Kim, Wook ^{[5
]}

Lee, Hyuk-Joon ^{[6
]}

Ryu, Seung Wan ^{[7
]}

Cho, Gyu Seok ^{[8
]}

Kim, Chan Young ^{[9
]}

Yang, Han-Kwang ^{[6
]}

Park, Do Joong ^{[1
]}

Song, Kyo Young ^{[10
]}

Lee, Sang I. L. ^{[11
]}

Ryu, Seong Yeob ^{[12
]}

Lee, Joo Ho ^{[13
]}

机构：

[1] Seoul Natl Univ, Bundang Hosp, Dept Surg, Coll Med, Songnam 463707, South Korea

[2] Ajou Univ, Sch Med, Dept Surg, Suwon 441749, South Korea

[3] Dong A Univ, Coll Med, Dept Surg, Pusan, South Korea

[4] Yonsei Univ, Coll Med, Dept Surg, Insititute Gastroenterol, Seoul, South Korea

[5] Catholic Univ Korea, Coll Med, Dept Surg, Yeouido St Marys Hosp, Seoul, South Korea

[6] Seoul Natl Univ, Coll Med, Dept Surg, Canc Res Inst, Seoul, South Korea

[7] Keimyung Univ, Sch Med, Dept Surg, Taegu, South Korea

[8] Soonchunhyang Univ, Coll Med, Dept Surg, Bucheon Hosp, Puchon, South Korea

[9] Chonbuk Natl Univ Hosp, Dept Surg, Jeonju, South Korea

[10] Catholic Univ Korea, Coll Med, Dept Surg, Seoul St Marys Hosp, Seoul, South Korea

[11] Chungnam Natl Univ Hosp, Dept Surg, Taejon, South Korea

[12] Chonnam Natl Univ, Sch Med, Dept Surg, Kwangju, South Korea

[13] Ewha Womans Univ, Mokdong Hosp, Dept Surg, Seoul, South Korea

来源：

JOURNAL OF THE KOREAN SURGICAL SOCIETY | 2013年 / 84卷 / 02期

关键词：

Gastric cancer; Laparoscopy distal gastrectomy; Open distal gastrectomy; Randomized controlled trial; OPEN SUBTOTAL GASTRECTOMY; LYMPH-NODE DISSECTION; ASSISTED GASTRECTOMY; CANCER; MULTICENTER; OUTCOMES;

D O I：

10.4174/jkss.2013.84.2.123

中图分类号：

R61 [外科手术学];

学科分类号：

100210 [外科学];

摘要：

A randomized controlled trial to evaluate the long-term outcomes of laparoscopic distal gastrectomy for gastric cancer is currently ongoing in Korea. Patients with cT1N0M0-cT2aN0M0 (American Joint Committee on Cancer, 6th edition) distal gastric cancer were randomized to receive either laparoscopic or open distal gastrectomy. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 cases each of laparoscopy-assisted distal gastrectomy and open distal gastrectomy and their institutions should have performed more than 80 cases each of both procedures each year. Fifteen surgeons from 12 institutions recruited 1,415 patients. The primary endpoint is overall survival. The secondary endpoints are disease-free survival, morbidity, mortality, quality of life, inflammatory and immune responses, and cost-effectiveness (ClinicalTrials.gov ID: NCT00452751).

引用

页码：123 / 130

页数：8

共 23 条

[1]

Changes in clinicopathological features and survival after gastrectomy for gastric cancer over a 20-year period [J].

Ahn, H. S. ;

Lee, H. -J. ;

Yoo, M. -W. ;

Jeong, S. -H. ;

Park, D. -J. ;

Kim, H. -H. ;

Kim, W. H. ;

Lee, K. U. ;

Yang, H. -K. .

BRITISH JOURNAL OF SURGERY, 2011, 98 (02) :255-260

[2]

[Anonymous], 1998, GASTRIC CANCER, V1, P10

[3]

Multicentre study of the safety of laparoscopic subtotal gastrectomy for gastric cancer in the elderly [J].

Cho, G. S. ;

Kim, W. ;

Kim, H. H. ;

Ryu, S. W. ;

Kim, M. C. ;

Ryu, S. Y. .

BRITISH JOURNAL OF SURGERY, 2009, 96 (12) :1437-1442

[4]

Fayers P, 2002, EUR J CANCER, V38, pS125

[5]

T lymphocyte subsets and Th1/Th2 balance after laparoscopy-assisted distal gastrectomy [J].

Fujii, K ;

Sonoda, K ;

Izumi, K ;

Shiraishi, N ;

Adachi, Y ;

Kitano, S .

SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2003, 17 (09) :1440-1444

[6]

Hahn Doug-Woong, 2005, [Korean Journal of Health Psychology, 한국심리학회지: 건강], V10, P183

[7]

Prospective randomized study of open vs laparoscopy-assisted distal gastrectomy with extraperigastric lymph node dissection for early gastric cancer [J].

Hayashi, H ;

Ochiai, T ;

Shimada, H ;

Gunji, Y .

SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2005, 19 (09) :1172-1176

[8]

Laparoscopic versus open subtotal gastrectomy for distal gastric cancer - Five-year results of a randomized prospective trial [J].

Huscher, CGS ;

Mingoli, A ;

Sgarzini, G ;

Sansonetti, A ;

Di Paola, M ;

Recher, A ;

Ponzano, C .

ANNALS OF SURGERY, 2005, 241 (02) :232-237

[9]

Actual 3-Year Survival After Laparoscopy-Assisted Gastrectomy for Gastric Cancer [J].

Hwang, Sun-Hwi ;

Park, Do Joong ;

Jee, Ye Seob ;

Kim, Min-Chan ;

Kim, Hyung-Ho ;

Lee, Hyuk-Joon ;

Yang, Han-Kwang ;

Lee, Kuhn Uk .

ARCHIVES OF SURGERY, 2009, 144 (06) :559-564

[10]

Laparoscopy-assisted total gastrectomy for gastric cancer: A multicenter retrospective analysis [J].

Jeong, Gui-Ae ;

Cho, Gyu-Seok ;

Kim, Hyung-Ho ;

Lee, Hyuk-Joon ;

Ryu, Seung-Wan ;

Song, Kyo-Young .

SURGERY, 2009, 146 (03) :469-474

← 1 2 3 →