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)

Wook Kim, Hyung Ho Kim, Sang Uk Han, Min Chan Kim, Woo Jin Hyung, Seung Wan Ryu, Gyu Seok Cho, Chan Young Kim, Han Kwang Yang, Do Joong Park, Kyo Young Song, Sang Il Lee, Seung Yub Ryu, Joo Ho Lee, Hyuk Joon Lee

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234 Citations (Scopus)

Abstract

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 intraabdominal 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.

Original languageEnglish
Pages (from-to)28-35
Number of pages8
JournalAnnals of surgery
Volume263
Issue number1
DOIs
Publication statusPublished - 2016 Jan 1

All Science Journal Classification (ASJC) codes

  • Surgery

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    Kim, W., Kim, H. H., Han, S. U., Kim, M. C., Hyung, W. J., Ryu, S. W., Cho, G. S., Kim, C. Y., Yang, H. K., Park, D. J., Song, K. Y., Lee, S. I., Ryu, S. Y., Lee, J. H., & Lee, H. J. (2016). 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). Annals of surgery, 263(1), 28-35. https://doi.org/10.1097/SLA.0000000000001346