NCT01875198终止不适用
Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Bleeding amount
研究概览
简要总结
When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ductal adenocarcinoma
- •Age ≥20 and ≤80
- •General performance status: the Karnofsky score> 70% or ECOG 0-1
- •Potentially Curative resection
- •Tumor size < 3cm
- •Pancreatic cancer located on neck or body portion
- •No invasion to spleen or spleen hilum
- •No combined resection except Lt. adrenal gland
- •Distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum
排除标准
- •Unresectable or locally advanced, metastatic case
- •Patients who do not want surgery
- •ASA (American society of anesthesiologists' physical status classification) score: ≥3
- •Patients with drug or alcohol addiction
- •Patients showing low compliance
- •Patients who not want to involve the clinical trial
- •Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
结局指标
主要结局
Bleeding amount
时间窗: 5 hours
次要结局
- average of pain score(admission period(about 5 days))
- time interval to adjuvant treatment(admission period(about 5 days))
- postoperative complication(admission period(about 5 days))
研究者
研究点 (2)
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