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).
OBJECTIVE
To determine the safety of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea.


BACKGROUND
There is still a lack of large-scale, multicenter randomized trials regarding the safety of LADG.


METHODS
A large-scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5-year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point


RESULTS
: A total of 1416 patients were randomly assigned to the LADG group (n = 705) or the ODG group (n = 711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention-to-treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively). In the PP analysis, 6 patients (0.9%) needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0% vs 19.9%, P = 0.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs 7.7%, P < 0.001). The major intra-abdominal complication (7.6% vs 10.3%, P = 0.095) and mortality rates (0.6% vs 0.3%, P = 0.687) were similar between the 2 groups. Modified ITT analysis showed similar results with PP analysis.


CONCLUSIONS
LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG.
*Department of Surgery, Yeouido St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea †Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea ‡Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea §Department of Surgery, Dong-A University College of Medicine, Busan, Republic of Korea ¶Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea ||Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea **Department of Surgery, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea ††Department of Surgery, Chonbuk National University Hospital, Jeonju, Republic of Korea ‡‡Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea §§Department of Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea ¶¶Department of Surgery, Chungnam National University Hospital, Daejeon, Republic of Korea ||||Department of Surgery, Chonnam National University Medical School, Gwangju, Republic of Korea ***Department of Surgery, EwhaWomans University Mokdong Hospital, Seoul, Republic of Korea.
Wook
W
Kim
Hyung-Ho
HH
Kim
Sang-Uk
SU
Han
Min-Chan
MC
Kim
Woo Jin
WJ
Hyung
Seung Wan
SW
Ryu
Gyu Seok
GS
Cho
Chan Young
CY
Kim
Han-Kwang
HK
Yang
Do Joong
DJ
Park
Kyo Young
KY
Song
Sang Il
SI
Lee
Seung Yub
SY
Ryu
Joo-Ho
JH
Lee
Hyuk-Joon
HJ
Lee
D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects* / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome