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)

Kim, Wook MD, PhD^*; Kim, Hyung-Ho MD, PhD^†; Han, Sang-Uk MD, PhD^‡; Kim, Min-Chan MD, PhD^§; Hyung, Woo Jin MD, PhD^¶; Ryu, Seung Wan MD, PhD^||; Cho, Gyu Seok MD, PhD^**; Kim, Chan Young MD, PhD^††; Yang, Han-Kwang MD, PhD^‡‡; Park, Do Joong MD, PhD^†; Song, Kyo Young MD, PhD^§§; Lee, Sang Il MD, PhD^¶¶; Ryu, Seung Yub MD, PhD^||||; Lee, Joo-Ho MD, PhD^***; Lee, Hyuk-Joon MD, PhD^‡‡; on behalf of the Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group

Annals of Surgery: January 2016 - Volume 263 - Issue 1 - p 28–35

doi: 10.1097/SLA.0000000000001346

Randomized Controlled Trials

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.

http://journals.lww.com/annalsofsurgery/Abstract/2016/01000/Decreased_Morbidity_of_Laparoscopic_Distal.6.aspx