Journal of Gastric Cancer

The Korean Gastric Cancer Association (대한위암학회)
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Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial)

  • Han Hong Lee (Division of Gastrointestinal Surgery, Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Chang Min Lee (Department of Surgery, Korea University College of Medicine) ;
  • Moon-Soo Lee (Department of Surgery, Eulji University Hospital) ;
  • In Ho Jeong (Department of Surgery, Jeju National University School of Medicine) ;
  • Myoung Won Son (Department of Surgery, Soonchunhyang University Hospital Cheonan) ;
  • Chang Hyun Kim (Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Moon-Won Yoo (Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Sung Jin Oh (Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine) ;
  • Young-Gil Son (Department of Surgery, Keimyung University Dongsan Medical Center) ;
  • Sung Il Choi (Department of Surgery, Kyung Hee University Hospital at Gangdong) ;
  • Mi Ran Jung (Department of Surgery, Chonnam National University Medical School) ;
  • Sang Hyuk Seo (Department of Surgery, Busan Paik Hospital, Inje University College of Medicine) ;
  • Shin-Hoo Park (Uijeongbu Eulji Medical Center, Eulji University College of Medicine) ;
  • Seong Ho Hwang (Department of Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Jae-Seok Min (Department of Surgery, Korea University College of Medicine) ;
  • Sungsoo Park (Department of Surgery, Korea University College of Medicine)
  • Received : 2023.01.12
  • Accepted : 2024.03.17
  • Published : 2024.07.01
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Abstract

Purpose: We conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality. Methods and Methods: The sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively. Results: The baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group. Conclusions: Short-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway.

Keywords

Acknowledgement

This study was financially supported by the National Research Foundation of Korea (Grant No. 2020R1A2C1012007). The authors acknowledge the financial support from Medtronic (ERP 2017-10901) for this study.

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