Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03) (KLASS-03)
Recruitment status was: Recruiting
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)|
- The incidence of postoperative morbidity and mortality [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
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, intra-abdominal fluid collection or abscess, intra-abdominal 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.
- the surgical outcomes according to the method of reconstruction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]We will evaluate the difference of surgical outcomes (duration of anastomosis, failure rate of anastomosis, etc) and postoperative morbidity (anastomotic leakage, stenosis, bleeding, etc) according to the methods of reconstruction after gastrectomy. The methods of reconstruction after gastrectomy will be depend to the each operator's decision.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: LATG group
It means the patients who will be enrolled in our study.
Other Name: Laparoscopy-assisted total gastrectomy (LATG)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584336
|Korea, Republic of|
|Soonchunhyang University Bucheon Hospital|
|Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-767|
|Ajou University Hospital|
|Suwon, Gyeonggi-do, Korea, Republic of, 443-749|
|Keimyung University Dongsan Medical Center|
|Daegu, Korea, Republic of, 700-712|
|Kyungpook National University medical Center|
|Daegu, Korea, Republic of, 702-210|
|Incheon St, Mary's Hostpial, The Catholic University of Korea|
|Incheon, Korea, Republic of, 403-720|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-799|
|Yonsei University Severance Hospital|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Gyu-Seok Cho, M.D., Ph.D.||Soonchunhyang University Hospital|