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临床试验/NCT04123080
NCT04123080已完成不适用

A Novel Technique Using Endoscopic Band Ligation for Removal of Long-stalked (>10 mm) Pedunculated Colon Polyps

Uijeongbu St. Mary Hospital0 个研究点目标入组 15 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
主要终点
Procedure time

研究概览

简要总结

Bleeding is the most common complication associated with polypectomy of large pedunculated colonic polyp. Although several techniques have been developed to minimize bleeding, none of these methods has become the gold standard. To prevent post-polypectomy bleeding effectively, the investigators developed and attempted a new endoscopic technique for removal of large long-stalked pedunculated colonic polyps using band ligations. This study aims to evaluate the safety and efficacy of a novel technique using endoscopic band ligation for removal of long-stalked pedunculated colon polyps.

详细描述

A prospective single-center study was conducted. Targeted polyps were large (head size >10 mm) with long stalk length (>10 mm) in the distal colon. After finding target lesions by standard colonoscopy, conventional upper endoscopy with rubber band (endoscopic band ligation, EBL) was applied to squeeze the mid-portion of the stalk to form an omega shape, which had the dual effect of ligation and compression of feeding blood vessels. After strangulation of the stalk, snare polypectomy was performed at the stalk site just above the ligation. The investigators evaluated several parameters, including completeness of resection, procedure time, and complications, including immediate postpolypectomy bleeding, delayed postpolypectomy bleeding, and perforation.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Polyps with head >10 mm and stalk length >10 mm;
  • Location at the distal segments of the colon; and
  • Benign features under endoscopic inspection (absence of ulceration and induration or friability).

排除标准

  • Patients who refuse to sign the consent

结局指标

主要结局

Procedure time

时间窗: during the procedure

From approaching the the stalk to snare polypectomy with electrosurgical snare

Rate of perforation

时间窗: 30 days after procedure

endoscopically observed colonic wall penetration, or perforation detected after endoscopy by radiological examination including abdomen CT.

Rate of completed polyp resection

时间窗: Immediately after the intervention

a lesion-free margin with both the lateral and basal tissues free of pathology

Rate of immediate postpolypectomy bleeding

时间窗: during the procedure

pulsating bleeding or oozing lasting more than 60 s immediately after polypectomy or requiring endoscopic intervention.

Rate of delayed postpolypectomy bleeding

时间窗: 30 days after procedure

gross rectal bleeding, bleeding requiring endoscopic or radiological hemostasis, or transfusions requiring surgery

次要结局

未报告次要终点

研究者

发起方
Uijeongbu St. Mary Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hiun Suk Chae

Professor

Uijeongbu St. Mary Hospital

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