Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial).
OBJECTIVE
The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality.


BACKGROUND
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.


CONCLUSIONS
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.
Kim
Hyung-Ho
HH
Seoul National University Bundang Hospital, Seongnam, Republic of Korea. hhkim@snubh.org
Hyung
Woo Jin
WJ
Cho
Gyu Seok
GS
Kim
Min Chan
MC
Han
Sang-Uk
SU
Kim
Wook
W
Ryu
Seung-Wan
SW
Lee
Hyuk-Joon
HJ
Song
Kyo Young
KY
D000328:Adult; D000368:Aged; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects* / Q000379:methods / Q000401:mortality*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000601:surgery*; D013997:Time Factors; D055815:Young Adult