Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer The KLASS-01 Randomized Clinical Trial

被引：451

作者：

Kim, Hyung-Ho ^{[1
]}

Han, Sang-Uk ^{[2
]}

Kim, Min-Chan ^{[3
]}

Kim, Wook ^{[4
]}

Lee, Hyuk-Joon ^{[5
]}

Ryu, Seung Wan ^{[6
]}

Cho, Gyu Seok ^{[7
]}

Kim, Chan Young ^{[8
]}

Yang, Han-Kwang ^{[5
]}

Park, Do Joong ^{[1
]}

Song, Kyo Young ^{[9
]}

Lee, Sang-Il ^{[10
]}

Ryu, Seong Yeob ^{[11
]}

Lee, Joo-Ho ^{[12
]}

Hyung, Woo Jin ^{[13
]}

Ahn, HyeSeong ^{[14
]}

Ahn, Sang-Hoon ^{[14
]}

Bae, Jae-Moon ^{[15
]}

Bae, Jung Min ^{[16
]}

Bae, Sung Joon ^{[17
]}

Byun, Cheul Su ^{[18
]}

Chang, Yeon Soo ^{[19
]}

Cho, Hyunjin ^{[20
]}

Cho, Minah ^{[22
]}

Choi, Chang In ^{[21
,23
]}

Choi, Kyeong-Woon ^{[24
]}

Choi, Seung-Ho ^{[25
]}

Choi, Sung Il ^{[26
]}

Chung, Ho-Young ^{[27
]}

Chung, Joo Won ^{[28
]}

Chung, Jung Kee ^{[29
]}

Eom, Bang Wool ^{[30
]}

Ha, Dongyeop ^{[31
]}

Ha, Man Ho ^{[32
]}

Ha, Taekyung ^{[33
]}

Han, Dong-Seok ^{[34
]}

Han, Sang-Mun ^{[35
]}

Han, Se Wung ^{[36
]}

Huh, Yeon-Ju ^{[37
]}

Hur, Hoon ^{[38
]}

Hwang, Sun-Hwi ^{[39
]}

Jang, You-Jin ^{[40
]}

Jee, Ye Seob ^{[41
]}

Jeong, Gui-Ae ^{[42
]}

Jeong, Inho ^{[43
]}

Jeong, Oh ^{[44
]}

Jeong, Sang-Ho ^{[45
]}

Jin, Sung-Ho ^{[46
]}

Jo, Ji Hoon ^{[47
]}

Jun, Kyong Hwa ^{[48
]}

机构：

[1] Seoul Natl Univ, Bundang Hosp, Dept Surg, Seongnam, South Korea

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

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

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

[5] Seoul Natl Univ, Coll Med, Dept Surg, Seoul, South Korea

[6] Keimyung Univ, Sch Med, Dept Surg, Daegu, South Korea

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

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

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

[10] Chungnam Natl Univ Hosp, Dept Surg, Daejeon, South Korea

[11] Chonnam Natl Univ, Sch Med, Dept Surg, Gwangju, South Korea

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

[13] Yonsei Univ, Coll Med, Dept Surg, 50-1 Yonsei Ro, Seoul 120752, South Korea

[14] Seoul Natl Univ, Seoul, South Korea

[15] Sungkyunkwan Univ, Seoul, South Korea

[16] Yeungnam Univ, Gyongsan, South Korea

[17] Korea Inst Radiol & Med Sci, Seoul, South Korea

[18] Ajou Univ, Suwon, South Korea

[19] Eulji Univ, Daejeon, South Korea

[20] Inje Univ, Gimhae, South Korea

[21] Soonchunhyang Univ, Asan, South Korea

[22] Yonsei Univ, Seoul, South Korea

[23] Pusan Natl Univ, Busan, South Korea

[24] Catholic Univ Korea, Seoul, South Korea

[25] Yonsei Univ, Seoul, South Korea

[26] Kyung Hee Univ, Seoul, South Korea

[27] Kyungpook Natl Univ, Daegu, South Korea

[28] Kosin Univ, Busan, South Korea

[29] Seoul Natl Univ, Seoul, South Korea

[30] Natl Canc Ctr, Goyang, South Korea

[31] Pohang St Marys Hosp, Pohang, South Korea

[32] Sungkyunkwan Univ, Seoul, South Korea

[33] Hanyang Univ, Seoul, South Korea

[34] Seoul Natl Univ, Seoul, South Korea

[35] CHA Univ, Pochon, South Korea

[36] Chonbuk Natl Univ, Jeonju, South Korea

[37] Ehwa Womans Univ, Seoul, South Korea

[38] Ajou Univ, Suwon, South Korea

[39] Pusan Natl Univ, Busan, South Korea

[40] Korea Univ, Seoul, South Korea

[41] Dankook Univ, Yongin, South Korea

[42] Soonchunhyang Univ, Asan, South Korea

[43] Jeju Natl Univ, Jeju City, South Korea

[44] Chonnam Natl Univ, Gwangju, South Korea

[45] Gyeongsang Natl Univ, Jinju, South Korea

[46] Korea Inst Radiol & Med Sci, Seoul, South Korea

[47] Kosin Univ, Busan, South Korea

[48] Catholic Univ Korea, Seoul, South Korea

[49] Andong Hosp, Andong, South Korea

[50] Korea Univ, Seoul, South Korea

来源：

JAMA ONCOLOGY | 2019年 / 5卷 / 04期

关键词：

SUPRAPANCREATIC NODAL DISSECTION; COMPARING OPEN; PHASE-III; OUTCOMES; MULTICENTER; SAFETY; ADENOCARCINOMA; METAANALYSIS; FEASIBILITY; SURGERY;

D O I：

10.1001/jamaoncol.2018.6727

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

IMPORTANCE Laparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes. However, to our knowledge, no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy. OBJECTIVE To examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy. DESIGN The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group, which includes 15 surgeons from 13 institutes, conducted a phase 3, multicenter, open-label, noninferiority, prospective randomized clinical trial (KLASS-01) of patients with histologically proven, preoperative clinical stage I gastric adenocarcinoma from January 5, 2006, to August 23, 2010. Survival and recurrence status of the patients was determined in December 2016. INTERVENTIONS Patients were randomly assigned (1: 1) to laparoscopic distal gastrectomy (n = 705) or open distal gastrectomy (n = 711). Of these patients, 85 received a surgical approach opposite the one to which they were randomized (63 randomized to the open surgery group and 22 to the laparoscopic group). MAIN OUTCOMES AND MEASURES Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups. The noninferiority margin was pre-specified as -5%(corresponding hazard ratio of 1.54), with an assumed survival of 90% after 5 years in the open surgery group. RESULTS Among the 1416 patients (mean [SD] age, 57.3 [11.1] years; 940 [66.4%] male) included in the study, the 5-year overall survival rates were 94.2% in the laparoscopic group and 93.3% in the open surgery group (log-rank P = .64). Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach (difference, 0.9 percentage points; 1-sided 97.5% CI, -1.6 to infinity). The 5-year cancer-specific survival rates were similar between the 2 groups (97.1% in the laparoscopic group and 97.2% in the open surgery group, log-rank P = .91; difference, -0.03 percentage points; 1-sided 97.5% CI, -1.8 to infinity). Per-protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates. CONCLUSIONS AND RELEVANCE The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy. Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00452751

引用

页码：506 / 513

页数：8

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