NCT06229197尚未招募不适用
Billroth II With Braun Anastomosis Versus Billroth II Anastomosis After Radical Distal Gastrectomy With D2 Lymphadenectomy for Gastric Cancer: a Randomized Controlled Trial
Sichuan University0 个研究点目标入组 176 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 主要终点
- Incidence of reflux gastritis assessed according to RGB classification
研究概览
简要总结
The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria:
- •Histologically proven stage I-III gastric cancer, evaluated as radically resectable
- •No synchronous or metachronous cancers
- •Patients have signed informed consent forms
- •Age 18-80 years old
- •No malfunction of cardio-pulmonary, liver, and kidney, ECOG score 0-1
- •No emergency surgery needed
排除标准
- •Patients will be excluded according to the following criteria:
- •Pregnant or lactating women
- •Distant metastasis to the liver, lung, bone, supraclavicular lymph nodes, pelvic, or ovarian species and peritoneal dissemination
- •Ascites or cachexia
- •Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes
- •Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials
- •Mental illness
- •Surgical history whose influence has not been eliminated
- •History of another gastric or esophageal malignancy, including stromal tumor, sarcoma, lymphoma, and carcinoid
- •Active infection with a fever of over 38°C
- •Poor compliance
- •Not suitable for this trial because of other clinical or laboratory conditions determined by the researchers
结局指标
主要结局
Incidence of reflux gastritis assessed according to RGB classification
时间窗: 6 months, 12 months
by endoscopic evaluation
次要结局
- Quality of life assessed by the PGSAS-45 Scale(6 months, 12 months)
- Nutritional status(6 months, 12 months)
- Time to first passage of flatus/stool(within 30 days after surgery)
- Postoperative complications (assessed according to the Clavien-Dindo)(within 30 days after surgery)
- Long-term complications(6 months, 12 months)
研究者
Bo Zhang, MD
Professor
Sichuan University
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