Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
试验速览
- 阶段
- 2 期
- 入组人数
- 168
- 试验地点
- 15
- 主要终点
- The incidence of postoperative morbidity and mortality
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This study will performed via prospective, multicenter design.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
- •range of age ; over 20 years to under 80 years
- •preoperative stage : cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC)
- •The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction
- •the gastric cancer which is not included the indication of the endoscopic mucosal dissection
- •ECOG (Eastern Cooperative Oncology Group) performance status; 0 and 1
- •ASA (American Society of Anesthesiology) score ; 1, 2, 3
- •Written informed consent
排除标准
- •The patient who shows distant metastasis under preoperative examination
- •The patient with medical history for upper abdominal surgery with open method in the past
- •The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past(remnant stomach cancer)
- •The patient with double cancer synchronous or metachronous within 5 years
- •Enlarged lymph nodes of the splenic hilum in the preoperative evaluation
- •The patient who has been enrolled other clinical study within 6 months
- •Vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy
研究组 & 干预措施
LATG group
It means the patients who will be enrolled in our study.
干预措施: LATG (Procedure)
结局指标
主要结局
The incidence of postoperative morbidity and mortality
时间窗: 1 month
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.
次要结局
- the surgical outcomes according to the method of reconstruction(1 month)
研究者
Gyu-Seok Cho
Soonchunhyang University Bucheon Hospital
Soonchunhyang University Hospital