Morbidity and Mortality after Laparoscopy-Assisted and Open Distal Gastrectomy for Stage I Gastric Cancer: Results from a Multicenter Randomised Controlled Trial (KLASS-01)

Wook Kim1, Hyung-Ho Kim2, Sang-Uk Han3, Min-Chan Kim4, Woo Jin Hyung5, Seung Wan Ryu6, Gyu Seok Cho7, Chan Young Kim8, Han-Kwang Yang9, Do Joong Park2, Kyo Young Song10, Sang Il Lee11, Seung Yub Ryu12, Joo-Ho Lee13, Dong Jin Kim1, Hyuk-Joon Lee9. 1Department of Surgery, Yeouido St. Mary’s Hospital, The Catholic University of Korea, 2Department of Surgery, Seoul National University Bundang Hospital, 3Department of Surgery, Ajou University School of Medicine, 4Dong-A University College of Medicine, Busan, 5Department of Surgery, Yonsei University College of Medicine, 6Department of Surgery, Keimyung University School of Medicine, 7Department of Surgery, Soonchunhyang University Bucheon Hospital, 8Department of Surgery, Chonbuk National University, 9Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, 10Department of Surgery, Seoul St. Mary’s Hospital, 11Department of Surgery, Chungnam National University Hospital, 12Department of Surgery, Chonnam National University Medical School, 13Department of Surgery, Ewha Womans University Mokdong Hospital

Purpose Morbidity and mortality results of phase III, multicenter randomized controlled trial (KLASS-01) comparing laparoscopy assisted distal gastrectomy (LADG) versus open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer will be reported.

Methods The morbidity within 30 postoperative days and the surgical mortality were compared. A total of 1,416 patients were randomly assigned to the LADG group (n = 705) or the ODG group (n = 711) between Feb 1, 2006 and Aug 31, 2010. Modified intention-to-treat (ITT) analysis group was defined after exclusion of the patients who met with post-randomization exclusion criteria. The patients who switched to the other group’s approach and underwent other than distal gastrectomy, or combined resection except cholecystectomy were not included in the per protocol analysis.

Results 1,256 were eligible for PP analysis (644 and 612, respectively). In surgical outcomes, LADG was associated with significantly longer operation time, less bleed loss, a shorter hospital stay, and a smaller number of retrieved lymph nodes. The overall complication rate was significantly lower in the LADG group (LADG vs. ODG; 13.0% vs. 19.9%, P = .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 < .001). The major intra-abdominal complication (7.6% vs. 10.3%, P = .095) and mortality rates (0.6% vs. 0.3%, P = .450) were similar between groups. Modified intention-to-treat 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.

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