Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2019 Jan;22(1):214-222.
doi: 10.1007/s10120-018-0864-4. Epub 2018 Aug 20.

A Feasibility Study of Laparoscopic Total Gastrectomy for Clinical Stage I Gastric Cancer: A Prospective Multi-Center Phase II Clinical Trial, KLASS 03

Affiliations
Clinical Trial

A Feasibility Study of Laparoscopic Total Gastrectomy for Clinical Stage I Gastric Cancer: A Prospective Multi-Center Phase II Clinical Trial, KLASS 03

Woo Jin Hyung et al. Gastric Cancer. .

Abstract

Background: With improved short-term surgical outcomes, laparoscopic distal gastrectomy has rapidly gained popularity. However, the safety and feasibility of laparoscopic total gastrectomy (LTG) has not yet been proven due to the difficulty of the technique. This single-arm prospective multi-center study was conducted to evaluate the use of LTG for clinical stage I gastric cancer.

Methods: Between October 2012 and January 2014, 170 patients with pathologically proven, clinical stage I gastric adenocarcinoma located at the proximal stomach were enrolled. Twenty-two experienced surgeons from 19 institutions participated in this clinical trial. The primary end point was the incidence of postoperative morbidity and mortality at postoperative 30 days. The severity of postoperative complications was categorized according to Clavien-Dindo classification, and the incidence of postoperative morbidity and mortality was compared with that in a historical control.

Results: Of the enrolled patients, 160 met criteria for inclusion in the full analysis set. Postoperative morbidity and mortality rates reached 20.6% (33/160) and 0.6% (1/160), respectively. Fifteen patients (9.4%) had grade III or higher complications, and three reoperations (1.9%) were performed. The incidence of morbidity after LTG in this trial did not significantly differ from that reported in a previous study for open total gastrectomy (18%).

Conclusions: LTG performed by experienced surgeons showed acceptable postoperative morbidity and mortality for patients with clinical stage I gastric cancer.

Keywords: Gastric cancer; Laparoscopy; Total gastrectomy.

Similar articles

See all similar articles

Cited by 6 articles

See all "Cited by" articles

References

    1. Ann Surg. 2004 Aug;240(2):205-13 - PubMed
    1. Surg Endosc. 2005 Jul;19(7):933-8 - PubMed
    1. Br J Surg. 2006 May;93(5):559-63 - PubMed
    1. World J Surg. 2006 Oct;30(10):1870-6; discussion 1877-8 - PubMed
    1. Surg Endosc. 2008 Apr;22(4):980-4 - PubMed

Publication types

MeSH terms

LinkOut - more resources

Feedback