Jejunal Pouch for Postoperative Quality of Life Following Roux-en-Y Reconstruction of Radical Total Gastrectomy: a Multicenter Randomized Controlled Trial (WCGCC-1202)
试验速览
- 阶段
- 3 期
- 入组人数
- 588
- 试验地点
- 9
- 主要终点
- Postoperative quality of life
研究概览
简要总结
Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of life, controversies still exist to the reconstruction methods of total gastrectomy. Although roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an easily and safety method reconstruction method, but some problems still need us to solve, such as little food reserves, less food intake per meal and fast gastric emptying. These problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch anastomosis is newly born method can significant increase the volume to improve postoperative quality of life have been proven by some little sample size randomized control trail With the improvement of the gastric cancer surgery, this study proposed by prospective randomized controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of life was evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy.
详细描述
Consecutive patients in each participant units and satisfied with inclusion/exclusion criteria will be informed the details, right, responsibility possible benefit and potential risks when after join in this study. Those patients who agree and sign informed consent document will randomized, consecutive case series sampling.
All the patients in the study and finished sampling would and must be recorded in the Western China Gastric Cancer Collaboration database and assign to corresponding treatment group.
Randomization allocation
After intraoperative exploration and predictively D2 radical (R0) total gastrectomy is possible to be performed, then assigned randomly to each subject on a 1:1 basis to either the Roux-en-Y+Pouch group or the Roux-en-Y group.
Surgical treatment
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of total gastrectomy;
- •Predictively resectable diseases, either early or locally advanced gastric cancer, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT1N0M0-T4aN3M0, I-IIIb, except T4b;
- •Age: 18-75 years;
- •Without serious disease;
- •WHO performance score < 2;
- •No limit to sexual and race;
- •Informed consent required
排除标准
- •Primary lesion cannot be resected in the pattern of transabdominal total gastrectomy, but for Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
- •Patients with other gastric malignant diseases, such as lymphoma and stromal tumors etc.
- •Patients suffering from malignant diseases before the study;
- •Patients with other severe comorbidities and cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (COPD), chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc.
- •Performed emergency operation due to bleeding or perforation;
- •Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- •Not the radical surgery, but with tumor residual (R1 or R2).
研究组 & 干预措施
Roux-en-Y+Pouch Group
Abdominal approach D2 total gastrectomy with Roux-en-Y+Pouch anastomosis. Roux-en-Y+Pouch anastomosis: closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm.
干预措施: Roux-en-Y+Pouch anastomosis (Procedure)
Roux-en-Y group
Abdominal approach D2 total gastrectomy with Roux-en-Y anastomosis. Roux-en-Y anastomosis : closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, œsophago-jejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm
干预措施: Roux-en-Y anastomosis (Procedure)
结局指标
主要结局
Postoperative quality of life
时间窗: 3 years
Postoperative quality of life is evaluated by the EORTC QLQ-C30 and the EORTC QLQ-STO22
次要结局
- Intraoperative morbidity and mortality(Intraoperative)
- Postoperative morbidity and mortality(within the first 30 days after surgery)
- Change of the postoperative body weight(3 years)
研究者
Jian-Kun Hu
Professor
West China Hospital