J Korean Surg Soc.  2013 Feb;84(2):123-130. 10.4174/jkss.2013.84.2.123.

Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)

Affiliations
  • 1Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea. hhkim@snubh.org
  • 2Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
  • 3Department of Surgery, Dong-A University College of Medicine, Busan, Korea.
  • 4Department of Surgery, Insititute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
  • 5Department of Surgery, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
  • 6Department of Surgery, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
  • 7Department of Surgery, Keimyung University School of Medicine, Daegu, Korea.
  • 8Department of Surgery, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
  • 9Department of Surgery, Chonbuk National University Hospital, Jeonju, Korea.
  • 10Department of Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
  • 11Department of Surgery, Chungnam National University Hospital, Daejeon, Korea.
  • 12Department of Surgery, Chonnam National University Medical School, Gwangju, Korea.
  • 13Department of Surgery, Ewha Womans University Mokdong Hospital, Seoul, Korea.

Abstract

A randomized controlled trial to evaluate the long-term outcomes of laparoscopic distal gastrectomy for gastric cancer is currently ongoing in Korea. Patients with cT1N0M0-cT2aN0M0 (American Joint Committee on Cancer, 6th edition) distal gastric cancer were randomized to receive either laparoscopic or open distal gastrectomy. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 cases each of laparoscopy-assisted distal gastrectomy and open distal gastrectomy and their institutions should have performed more than 80 cases each of both procedures each year. Fifteen surgeons from 12 institutions recruited 1,415 patients. The primary endpoint is overall survival. The secondary endpoints are disease-free survival, morbidity, mortality, quality of life, inflammatory and immune responses, and cost-effectiveness (ClinicalTrials.gov ID: NCT00452751).

Keyword

Gastric cancer; Laparoscopy distal gastrectomy; Open distal gastrectomy; Randomized controlled trial

MeSH Terms

Adenocarcinoma
Disease-Free Survival
Gastrectomy
Humans
Joints
Korea
Prospective Studies
Quality Control
Quality of Life
Stomach Neoplasms

Figure

  • Fig. 1 Scheme diagram of the stydy. AJCC/UICC, American Joint Committee on Cancer/Union for International Cancer Control; ODG, open distal gastrectomy; LADG, laparoscopy-assisted distal gastrectomy; CRF, case report form.


Cited by  2 articles

Learning Curve of Pure Single-Port Laparoscopic Distal Gastrectomy for Gastric Cancer
Boram Lee, Yoon Taek Lee, Young Suk Park, Sang-Hoon Ahn, Do Joong Park, Hyung-Ho Kim
J Gastric Cancer. 2018;18(2):182-188.    doi: 10.5230/jgc.2018.18.e20.

Laparoscopic Proximal Gastrectomy as a Surgical Treatment for Upper Third Early Gastric Cancer
Do Joong Park, Young Suk Park, Sang-Hoon Ahn, Hyung-Ho Kim
Korean J Gastroenterol. 2017;70(3):134-140.    doi: 10.4166/kjg.2017.70.3.134.


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