A Prospective Comparative Study of Papillectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- complete resection
研究概览
简要总结
Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.
详细描述
While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy.
In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ampulla of Vater adenoma
- •no uncontrolled coagulopathy
排除标准
- •adenocarcinoma of ampulla of Vater
- •uncontrolled coagulopathy
- •refusal to this study
研究组 & 干预措施
Papillectomy without injection
Conventional snaring mucoal resection without submucosal injection
干预措施: Papillectomy without injection (Procedure)
Papillectomy with injection
Conventional mucosal resction method following injeciton of diluted epinephrine mixture.
干预措施: Papillectomy with injection (Procedure)
结局指标
主要结局
complete resection
时间窗: one month
Following endoscopic papillectomy, complete resection will be estimated by pathologic examination
次要结局
- complication(within 24 hours)
研究者
Tae Hoon Lee
MD
Soon Chun Hyang University