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临床试验/NCT03037034
NCT03037034已完成不适用

Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria: a Promising Forcep Strip Method

Korea University Anam Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Complete resection rate

研究概览

简要总结

Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive patients who had clinical indications for lesion removal. Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current. In brief, the tumor was dissected from the muscularis propria layer and then carefully removed using forceps. Demographic data, indication for intervention, safety of the procedure and follow-up will be assessed.

详细描述

After the target lesion was identified, several marking dots were made around the lesion, using the hot biopsy forcep. A 0.9% saline solution mixed with epinephrine (1:10,000) and indigo carmine dye was injected along the border of the tumor to raise the gastric mucosa. Then, a circumferential incision was made along the margin of the targeted lesion, using the hot biopsy forceps, and the superficial mucosa was removed. Repeated injection was performed into the submucosal layer. The surrounding tissue was then carefully dissected using the hot biopsy forceps to the level of the deepest submucosal layer. The adjacent tissue was grasped using the forceps and pulled away, forming a "tent". To ensure complete resection, the muscular fibers and stalks that connected the tumor to the propria layer were shelled along the capsule of the tumor, using the coagulating forceps. The investigators used a coagulating forceps when strip the tissue of the outer longitudinal layer. Visible blood vessels in the submucosal layer were directly coagulated using coagulating forceps. After the lesion was removed, further visible blood vessels were coagulated. The hot biopsy forcep was used to apply a forced coagulation current (80 W, Effect 2, VIO300D; Erbe, Germany). However, coagulating forceps with a soft coagulation current (60 W, Effect 6, VIO300D; Erbe, Germany) were used to cut muscle fibers adjacent to the tumor or hemostasis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the tumor size had increased on the follow up gastroscopy,
  • the EUS showed a well demarcated GI SET, or
  • they requested an endoscopic excision because the tumor was causing them anxiety.

排除标准

  • they had predominantly extraluminal growth,
  • they were ill demarcated, or
  • the EUS showed adjacent lymph nodes with a malignant appearance.

结局指标

主要结局

Complete resection rate

时间窗: 1 week

Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method

次要结局

  • The mean procedure time(1day)
  • Adverse Events(5 days)
  • mean tumor size(1day)
  • the mean hospitalization time(1week)
  • Tumor status after endoscopic resection(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

In-Kyung Yoo

Clinical Professor

Korea University Anam Hospital

研究点 (2)

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