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Morbidity and Mortality of Laparoscopic Gastrectomy Versus Open Gastrectomy for Gastric Cancer: An Interim Report—A Phase III Multicenter, Prospective, Randomized Trial (KLASS Trial)

Kim, Hyung-Ho MD*; Hyung, Woo Jin MD; Cho, Gyu Seok MD; Kim, Min Chan MD§; Han, Sang-Uk MD; Kim, Wook MD; Ryu, Seung-Wan MD**; Lee, Hyuk-Joon MD††; Song, Kyo Young MD‡‡

doi: 10.1097/SLA.0b013e3181cc8f6b
Randomized Controlled Trial

Objective: The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality.

Summary Background Data: Laparoscopic-assisted distal gastrectomy (LADG) is rapidly gaining popularity. However, there is limited evidence regarding its oncologic safety. We therefore conducted a phase III multicenter, prospective, randomized study comparing LADG with open gastrectomy (ODG).

Methods: Patient eligibility criteria were pathologically-proven adenocarcinoma, 20 to 80 years of age, preoperative stage I, no history of other cancer, chemotherapy, or radiotherapy. The primary end point was to determine whether there is a difference in overall survival between 2 groups. The morbidity and mortality were compared to evaluate the safety of this trial. The time was decided on the hypothesis that the morbidity of this trial was not significantly different from that of previous reports on open gastric cancer surgeries (17%–20%). This study is registered at ClinicalTrials.gov and carries the following ID number: NCT00452751.

Results: A total of 342 patients were randomized (LADG, 179 patients; ODG, 161 patients) between January 1, 2006 and July 19, 2007. There were no significant differences between the 2 groups in age, gender, and comorbidities. The postoperative complication rates of the LADG and ODG groups were 10.5% (17/179) and 14.7% (24/163), respectively (P = 0.137). Reoperations were required in 3 cases each group. The postoperative mortality was 1.1% (2/179) and 0% (0/163) in the LADG and ODG groups (P = 0.497), respectively.

Conclusion: There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.

Laparoscopic-assisted distal gastrectomy (LADG) is rapidly gaining in popularity. However, there is limited evidence regarding its oncologic safety. We conducted a phase III multicenter, prospective, randomized study comparing LADG with open gastrectomy. We found no significance difference in the morbidity and mortality between the LADG and open gastrectomy groups. Therefore, we conclude that this trial was safe and is thus ongoing.

From the *Seoul National University Bundang Hospital, Seongnam, Republic of Korea; †Yonsei University College of Medicine, Seoul, Republic of Korea; ‡Soonchunhyang University College of Medicine, Bucheon, Republic of Korea; §Dong-A University College of Medicine, Pusan, Republic of Korea; ¶Ajou University College of Medicine, Suwon, Republic of Korea; ∥Catholic University Holy Family Hospital, Bucheon, Republic of Korea; **Keimyung University College of Medicine, Daegu, Republic of Korea; ††Seoul National University Hospital, Seoul, Republic of Korea; and ‡‡Catholic University Kangnam St. Mary's Hospital, Seoul, Republic of Korea.

Reprints: Hyung-Ho Kim, MD, PhD, Department of Surgery, Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi, Korea. E-mail: hhkim@snubh.org.

© 2010 Lippincott Williams & Wilkins, Inc.