NCT06001476Unknown4 期
Feasibility and Safety Analysis of Cold Snare Polypectomy in 5-9mm Small Intestinal Polyp Resection in Patients With Peutz-Jeghers Syndrome: A Prospective, Interventional Study
Shandong University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS
研究概览
简要总结
This study aims to evaluate the feasibility and safety of Cold snare polypectomy for removing 5-9mm small intestinal polyps in patients with Peutz-Jeghers Syndrome (PJS),in order to provide some reference for clinical strategy of endoscopic treatment of small intestinal polyps in PJS patients, and may prolong the follow-up period of PJS patients Intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-60, male or female.
- •Diagnosed with Peutz-Jeghers Syndrome
- •Undergo enteroscopy for small bowel polypectomy.
排除标准
- •Absence of at least one study polyp (5-9mm stubby pedicle, wide pedicle and sessile small bowel polyps);
- •Be evaluated during enteroscopy for requiring surgical intervention (such as endoscopically difficult to handle giant polyps, intussusception, etc.)；
- •With more than 50 polyps ≥1cm found in this enteroscopy examination;
- •The polyp has been confirmed to be malignant by pathology, or highly suspicious of malignant transformation under endoscopy;
- •Receiving anticoagulant therapy during this treatment;
- •Unable or unwilling to provide informed consent.
结局指标
主要结局
Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS
时间窗: 28 days after the procedure
The complications include complications during CSP and complications occurring within 28 days after enteroscopy
次要结局
- Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy(Immediately after the procedure)
- Incidence of complications within 28 days after enteroscopy(28 days after the procedure)
研究者
Xiuli Zuo
Director of Qilu Hospital gastroenterology department
Shandong University
研究点 (1)
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