A Multicenter Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopy-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric cancer_KLASS 07 (CKLASS01)(Korea-China Collaborated Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Postoperative 30-day morbidity rate
研究概览
简要总结
The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.
详细描述
The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery.
Early postoperative morbidity is classified as follows:
(1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc.
The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
- •Age between 20 and 80 years old
- •Eastern Cooperative Oncology Group performance statu of 0 or 1
- •Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the American Joint Committee on Cancer system10 (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
- •Scheduled for laparoscopic distal gastrectomy with D1+ or D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2010 (ver.3).)
- •Patients who gave a consent and signed the formal paper permitted by Institutional Review Board (IRB) after hearing a full description of the study (purpose and contents) prior to the participation
排除标准
- •Patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past
- •Patients with intraabdominal adhesion due to previous intraperitoneal surgery
- •Patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy
- •Patients who requires combined organ resection due to aggression of gastric cancer or other diseases
- •Patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions).
- •Vulnerable people who can't communicate or are pregnant (or planning to be pregnant)
- •Patients who are currently participating or participated in other clinical trials in the last six months.
研究组 & 干预措施
TLDG arm
TLDG arm(Totally laparoscopic distal gastrectomy)
: After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.
干预措施: TLDG arm (Procedure)
LADG arm
LADG arm(Laparoscopy-assisted distal gastrectomy)
: After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy
干预措施: LADG arm (Procedure)
结局指标
主要结局
Postoperative 30-day morbidity rate
时间窗: Postoperative 30-day
Check the morbidity rate :Wound, seroma, hematoma, wound infection, wound dehiscence, wound evisceration, Fluid collection/Abscess, Intraabdominal bleeding, Intraluminal bleeding, Postoperative ileus, Anastomosis stenosis, Anastomosis leakage, Pancreatitis or pancreatic fistula, Complication(Pulmonary, Urinary, Renal, Hepatic, Cardiac, Endocrine) etc.
次要结局
- QOL measurement : EORTC QLQ-C30/STO22(screening(pre op) / Postoperative 30-day,3-month,6-month,12-month)
研究者
Sungsoo Park
Professor
Korea University Anam Hospital