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

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

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.

KMID: 2145001
DOI: http://doi.org/10.4174/jkss.2013.84.2.123

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

Abstract

Keyword

MeSH Terms

Figure

Cited by 2 articles

Reference

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