Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy With Nodal Dissection for Clinical Stage I Gastric Cancer (KLASS-03)
Gastric cancer remains one of the most common neoplasms in Asia and some western countries,
although the incidence is decreasing worldwide. Recently,as the rate of detection of early
gastric cancer has increased and surgical techniques have been developed, laparoscopic
procedures have been introduced and tried for the treatment of early-stage gastric cancer.
Already the prospective, randomized trials for safety and oncologic outcomes of
laparoscopy-assisted distal gastrectomy for gastric cancer had been tried, but the
large-scaled, prospective study for laparoscopy-assisted total gastrectomy (LATG) is seldom.
One reason for the low popularity is that LATG requires the dissection of lymph nodes at the
splenic hilum or along the short gastric arteries and the other reason is that the
reconstruction after total gastrectomy is also more complicated. The third reason is that
the chance for total gastrectomy is less frequent than distal gastrectomy because of the low
incidence of upper gastric cancer.
This KLASS-03 trial is a prospective, multicenter trial for LATG for early upper gastric
cancer. The primary purpose of this study is to evaluate the incidence of postoperative
morbidity and mortality and the second purpose is to evaluate the surgical outcomes after
several methods of reconstruction in laparoscopic total gastrectomy and the postoperative
course of LATG patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The incidence of postoperative morbidity and mortality
The primary purpose of this study is that the incidence of morbidity and mortality after LATG. We will access the postoperative morbidity including as follows: wound complication, intraabdominal fluid collection or abscess, intraabdominal bleeding, intraluminal bleeding, intestinal obstruction, ileus, anastomotic stenosis, anastomotic leakage, fistula, pancreatitis, pulmonary complication, urinary complication, renal complication, hepatic complication, cardiac complication, endocrine complication, and stasis. Also we will evaluate the incidence of postoperative mortality after LATG
Gyu-Seok Cho, M.D., Ph.D.
Soonchunhyang University Bucheon Hospital
South Korea: Institutional Review Board