跳至主要内容
临床试验/NCT05479825
NCT05479825招募中不适用

Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined With Fluorography

The Second Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
perioperative complication rate

研究概览

简要总结

Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic).

Methods: A one- armed, prospective randomized controlled study was designed. The intersegmental plane was not so clear during the tubeless minimally invasive segmentectomy, and the presentation of the plane sometimes cost more time. This study will evaluate consecutive patients with the combination of inflation- deflation method and fluorography with the ICG injection.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cardio- pulmonary function can tolerate the minimally invasive surgery (including VATS and robotic surgery);
  • benign pulmonary lesion considering for segmentectomy;
  • ≤2cm pulmonary adenocarcinoma with ground- glass components, considering for segmentectomy.

排除标准

  • cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
  • segmentectomy is not considered as the surgery plan.

结局指标

主要结局

perioperative complication rate

时间窗: within 7 days after surgery

perioperative complication rate

incisal margin of the tumor

时间窗: during surgery

incisal margin of the tumor

time of description and management of the intersegmental plane

时间窗: during surgery

time of description and management of the intersegmental plane

次要结局

  • disease- free survival(within 5 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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