Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013 Feb;84(2):123-30.
doi: 10.4174/jkss.2013.84.2.123. Epub 2013 Jan 29.

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

Hyung-Ho Kim  1 , Sang-Uk Han, Min-Chan Kim, Woo Jin Hyung, Wook Kim, Hyuk-Joon Lee, Seung Wan Ryu, Gyu Seok Cho, Chan Young Kim, Han-Kwang Yang, Do Joong Park, Kyo Young Song, Sang Il Lee, Seong Yeob Ryu, Joo Ho Lee; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group
Affiliations

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

Hyung-Ho Kim et al. J Korean Surg Soc. 2013 Feb.

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).

Keywords: Gastric cancer; Laparoscopy distal gastrectomy; Open distal gastrectomy; Randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1
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.
See this image and copyright information in PMC

References

    1. Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994;4:146–148. - PubMed
    1. Huscher CG, Mingoli A, Sgarzini G, Sansonetti A, Di Paola M, Recher A, et al. Laparoscopic versus open subtotal gastrectomy for distal gastric cancer: five-year results of a randomized prospective trial. Ann Surg. 2005;241:232–237. - PMC - PubMed
    1. Hayashi H, Ochiai T, Shimada H, Gunji Y. Prospective randomized study of open versus laparoscopy-assisted distal gastrectomy with extraperigastric lymph node dissection for early gastric cancer. Surg Endosc. 2005;19:1172–1176. - PubMed
    1. Kitano S, Shiraishi N, Fujii K, Yasuda K, Inomata M, Adachi Y. A randomized controlled trial comparing open vs laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer: an interim report. Surgery. 2002;131(1 Suppl):S306–S311. - PubMed
    1. Kim MC, Kim KH, Kim HH, Jung GJ. Comparison of laparoscopy-assisted by conventional open distal gastrectomy and extraperigastric lymph node dissection in early gastric cancer. J Surg Oncol. 2005;91:90–94. - PubMed

Associated data