跳至主要内容
临床试验/NCT03793387
NCT03793387Unknown不适用

Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial

National Taiwan University Hospital Hsin-Chu Branch2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Successful localization

研究概览

简要总结

Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

详细描述

Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be performed in the operating room (OR) under general anesthesia without extra radiation exposure, which is expected to reduce the discomfort for the patient during localization. This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 40 patients with pulmonary nodules will be randomly assigned into two groups. One group will receive bronchoscopic dye localization in the hybrid examination room equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye localization in OR. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

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
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20~90 years old C. sign permit

排除标准

  • A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F. Immunocompromised G. Severe infection H. Unable to sign permit

结局指标

主要结局

Successful localization

时间窗: 2 days

Discrepancy from lesion to marking: less than 1 cm

Successful resection

时间窗: 2 days

Lesion contained in first resected specimen

次要结局

  • Complication(14 days)
  • Localization duration(1 day)
  • Total radiation exposure(2 days)

研究者

发起方
National Taiwan University Hospital Hsin-Chu Branch
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验