Short-term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial)

被引:58
作者
Park, D. J. [1 ,2 ,3 ]
Kim, Y-W [4 ]
Yang, H-K [1 ,2 ]
Ryu, K. W. [4 ]
Han, S-U [5 ]
Kim, H-H [3 ]
Hyung, W-J [6 ]
Park, J. H. [7 ]
Suh, Y-S [1 ,2 ,3 ]
Kwon, O. K. [8 ]
Yoon, H. M. [4 ]
Kim, W. [9 ]
Park, Y-K [10 ]
Kong, S-H [1 ,2 ]
Ahn, S. H. [3 ]
Lee, H-J [1 ,2 ]
机构
[1] Seoul Natl Univ, Seoul Natl Univ Hosp, Dept Surg, Coll Med, Seoul, South Korea
[2] Seoul Natl Univ, Seoul Natl Univ Hosp, Canc Res Inst, Coll Med, Seoul, South Korea
[3] Seoul Natl Univ, Bundang Hosp, Dept Surg, Coll Med, Seongnam, South Korea
[4] Natl Canc Ctr, Dept Surg, Goyang, South Korea
[5] Ajou Univ Hosp, Dept Surg, Suwon, South Korea
[6] Yonsei Univ, Dept Surg, Severance Hosp, Seoul, South Korea
[7] Gyeongsang Natl Univ Hosp, Dept Surg, Daegu, South Korea
[8] Kyungpook Natl Univ Hosp, Dept Surg, Daegu, South Korea
[9] Catholic Univ Korea, Dept Surg, Yeouido St Marys Hosp, Seoul, South Korea
[10] Chonnam Natl Univ, Dept Surg, Med Sch, Hwasun, South Korea
关键词
RISK-FACTORS; CRITERIA; STOMACH;
D O I
10.1093/bjs/znab295
中图分类号
R61 [外科手术学];
学科分类号
摘要
Background: There remain concerns about the safety and functional benefit of laparoscopic pylorus-preserving gastrectomy (LPPG) compared with laparoscopic distal gastrectomy (LDG). This study evaluated short-term outcomes of a randomized clinical trial (RCT) comparing LPPG with LDG for gastric cancer. Methods: The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS)-04 trial was an investigator-initiated, open-label, parallel-assigned, superiority, multicentre RCT in Korea. Patients with cT1N0M0 cancer located in the middle third of the stomach at least 5 cm from the pylorus were randomized to undergo LPPG or LDG. Participants, care givers and those assessing the outcomes were not blinded to group assignment. Outcomes were 30-day postoperative morbidity rate and death at 90 days. Results: Some 256 patients from nine institutions were randomized (LPPG 129 patients, LDG 127 patients) between July 2015 and July 2017 and outcomes for 253 patients were analysed. Postoperative complications within 30 days were seen in 19.3 and 15.5 per cent in the LPPG and LDG groups respectively (P = 0.419). Postoperative pyloric stenosis was observed in nine (7.2 per cent) and two (1.5 per cent) patients in the LPPG and LDG groups (P = 0.026) respectively. In multivariable analysis higher BMI was a risk factor for postoperative complications (odds ratio 1.17, 95 per cent c.i. 1.04 to 1.32; P = 0.011). Death at 90 days was zero in both groups. Conclusion: Postoperative complications and mortality was comparable in patients undergoing LPPG and LDG.
引用
收藏
页码:1043 / 1049
页数:7
相关论文
共 28 条
[1]   The Clavien-Dindo Classification of Surgical Complications Five-Year Experience [J].
Clavien, Pierre A. ;
Barkun, Jeffrey ;
de Oliveira, Michelle L. ;
Vauthey, Jean Nicolas ;
Dindo, Daniel ;
Schulick, Richard D. ;
de Santibanes, Eduardo ;
Pekolj, Juan ;
Slankamenac, Ksenija ;
Bassi, Claudio ;
Graf, Rolf ;
Vonlanthen, Rene ;
Padbury, Robert ;
Cameron, John L. ;
Makuuchi, Masatoshi .
ANNALS OF SURGERY, 2009, 250 (02) :187-196
[2]  
Edge S.B., 2010, AJCC CANC STAGING HD
[3]   Japanese gastric cancer treatment guidelines 2018 (5th edition) [J].
Japanese Gastric Cancer Association .
GASTRIC CANCER, 2021, 24 (01) :1-21
[4]   Postoperative Outcomes and Complications After Laparoscopy-assisted Pylorus-preserving Gastrectomy for Early Gastric Cancer [J].
Jiang, Xiaohua ;
Hiki, Naoki ;
Nunobe, Souya ;
Fukunaga, Tetsu ;
Kumagai, Koshi ;
Nohara, Kyoko ;
Sano, Takeshi ;
Yamaguchi, Toshiharu .
ANNALS OF SURGERY, 2011, 253 (05) :928-933
[5]   Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach [J].
Ryu K.W. ;
Park Y.S. ;
Kwon O.K. ;
Oh J. ;
Lee H.H. ;
Kong S.H. ;
Son T. ;
Hur H. ;
Jee Y.S. ;
Yoon H.M. ;
Kim C. ;
Min B.-H. ;
Song H.-J. ;
Shin W.G. ;
Lee S.K. ;
Jang J.-Y. ;
Jung H.-K. ;
Ryu M.-H. ;
Sym S.J. ;
Oh S. ;
Shim B.Y. ;
Zang D.Y. ;
Han H.S. ;
Koo D.-H. ;
Kim H.S. ;
Maeng C.H. ;
Hwang I.G. ;
Yu J.I. ;
Chie E.K. ;
Kim J.M. ;
Kim B.-H. ;
Kook M.-C. ;
Lee H.S. ;
Choi M. ;
Kim C.-Y. ;
Jin S. ;
Park J.M. ;
Shin C.M. ;
Oh D.-Y. ;
Lee K.-W. ;
Kim T.-H. ;
Kim K.-M. .
JOURNAL OF GASTRIC CANCER, 2019, 19 (01) :1-48
[6]   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 [J].
Kim, Hyung-Ho ;
Han, Sang-Uk ;
Kim, Min-Chan ;
Kim, Wook ;
Lee, Hyuk-Joon ;
Ryu, Seung Wan ;
Cho, Gyu Seok ;
Kim, Chan Young ;
Yang, Han-Kwang ;
Park, Do Joong ;
Song, Kyo Young ;
Lee, Sang-Il ;
Ryu, Seong Yeob ;
Lee, Joo-Ho ;
Hyung, Woo Jin ;
Ahn, HyeSeong ;
Ahn, Sang-Hoon ;
Bae, Jae-Moon ;
Bae, Jung Min ;
Bae, Sung Joon ;
Byun, Cheul Su ;
Chang, Yeon Soo ;
Cho, Hyunjin ;
Cho, Minah ;
Choi, Chang In ;
Choi, Kyeong-Woon ;
Choi, Seung-Ho ;
Choi, Sung Il ;
Chung, Ho-Young ;
Chung, Joo Won ;
Chung, Jung Kee ;
Eom, Bang Wool ;
Ha, Dongyeop ;
Ha, Man Ho ;
Ha, Taekyung ;
Han, Dong-Seok ;
Han, Sang-Mun ;
Han, Se Wung ;
Huh, Yeon-Ju ;
Hur, Hoon ;
Hwang, Sun-Hwi ;
Jang, You-Jin ;
Jee, Ye Seob ;
Jeong, Gui-Ae ;
Jeong, Inho ;
Jeong, Oh ;
Jeong, Sang-Ho ;
Jin, Sung-Ho ;
Jo, Ji Hoon ;
Jun, Kyong Hwa .
JAMA ONCOLOGY, 2019, 5 (04) :506-513
[7]   Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01) [J].
Kim, Wook ;
Kim, Hyung-Ho ;
Han, Sang-Uk ;
Kim, Min-Chan ;
Hyung, Woo Jin ;
Ryu, Seung Wan ;
Cho, Gyu Seok ;
Kim, Chan Young ;
Yang, Han-Kwang ;
Park, Do Joong ;
Song, Kyo Young ;
Lee, Sang Il ;
Ryu, Seung Yub ;
Lee, Joo-Ho ;
Lee, Hyuk-Joon .
ANNALS OF SURGERY, 2016, 263 (01) :28-35
[8]  
KITANO S, 1994, SURG LAPAROSC ENDOSC, V4, P146
[9]   Analysis of risk factors for the development of gallstones after gastrectomy [J].
Kobayashi, T ;
Hisanaga, M ;
Kanehiro, H ;
Yamada, Y ;
Ko, S ;
Nakajima, Y .
BRITISH JOURNAL OF SURGERY, 2005, 92 (11) :1399-1403
[10]   EARLY POSTOPERATIVE EVALUATION OF PYLORUS-PRESERVING GASTRECTOMY FOR GASTRIC-CANCER [J].
KODAMA, M ;
KOYAMA, K ;
CHIDA, T ;
ARAKAWA, A ;
TUR, G .
WORLD JOURNAL OF SURGERY, 1995, 19 (03) :456-461