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临床试验/NCT05344430
NCT05344430招募中不适用

CT Guided and Cone Beam CT Guided Percutaneous Transthoracic Needle Biopsy: A Comparison of Pneumothorax Incidence and Associated Risk Factors

Northwell Health2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月8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
100
试验地点
2
主要终点
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy

研究概览

简要总结

The goal of this study is to determine if cone beam computed tomography (CBCT) is a viable alternative imaging guidance modality for percutaneous transthoracic needle biopsy (PTNB) in a community hospital-based practice, and to determine the incidence of CBCT PTNB-associated pneumothorax compared to multidetector computed tomography (MDCT) guided PTNB biopsy. The standard of care in this facility is MDCT guided PTNB biopsy. The experimental arm of this study is CBCT-guided PTNB biopsy.

This prospective study will identify patients planned for PTNB. Thereafter, data on lesion characteristics, imaging findings, and clinical history will be collected. Patients will be subsequently randomly assigned to undergo biopsy using either CBCT or MDCT guidance. This study will analyze the pneumothorax incidence between groups, and assess for associations between lesion size/location, pertinent imaging findings, and clinical risk factors.

详细描述

Studies have shown that CBCT is a viable imaging modality for PTNB. Although MDCT-guidance remains the preferred procedural modality, research has shown that CBCT-guided biopsies can be carried out safely and effectively. Particularly, studies demonstrate a satisfactory diagnostic yield, low complication rate, and overall reduced patient radiation dose. However, only a handful of studies have compared this method to MDCT-guided biopsy.

In this 248-bed community hospital-based interventional radiology practice, C-Arm CBCT was successfully utilized during a three-month period when a dedicated procedural CT scanner was out of service prior to the installation of a new machine. During this time, CBCT was used to perform PTNB. This study was prompted given the operators' perception that there was an overall increased incidence of biopsy-associated pneumothoraxes. Given this subjective experience, a retrospective analysis was carried out comparing the complication rate during these three months to the preceding six-month period, when MDCT-guidance was primarily used.

For the primary analysis, patients were grouped based on imaging modality (CBCT n=37; CT n=64). Multiple Pearson Chi-Square Tests were carried out using p=.05 as the statistical threshold. Additional analyses dividing patient based on lesion size (≥/< 2 cm in diameter), lesion pleural depth (≥/< 2 cm pleural depth), bullous lung change on imaging, chest tube placement, history of COPD, and smoking history were also carried out to assess for related pneumothorax risk factors.

The investigators found no significant association between the imaging modality used for PTNB and subsequent pneumothorax (p=.69). However, there was a significant interaction between chest tube placement and diagnosed chronic obstructive pulmonary disease (COPD) (p=.03), where among all study subjects, 6 of the 8 patients requiring a chest tube had a history of chronic obstructive pulmonary disease (COPD). Additionally, all patients requiring chest tube placement were either current or former smokers. This finding approached but did not reach statistical significance (p=0.12).

This study did not confirm the perceived increased pneumothorax rate. However, the findings corroborate previously published literature, where complication rates between CBCT and MDCT-guidance are reportedly comparable. This experience demonstrates that CBCT can be successfully utilized in a community hospital setting, where limited resources often prompt the need for alternative and innovative procedural approaches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Patients scheduled for lung biopsy at Mather Hospital's Department of Interventional Radiology.
  • Patients ages from 18 years old to 90 years old.

排除标准

  • High risk patients will be excluded from the study.
  • ( High risk - Any patient with severe emphysema with bullous emphysema on baseline Computed Tomography of the Chest, intended biopsy target/nodule adjacent to an airway or central vasculature, or less than 1 cm in size)
  • Patients less than 18 years old
  • Patients older than 90 years old
  • patients who lack mental capacity for medical decision making
  • Any patient requiring or requesting general anesthesia for the intended procedure

结局指标

主要结局

To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy

时间窗: Up to 24 hours post biopsy procedure

rate of pneumothorax

次要结局

  • To compare the the amount of intravenous fentanyl used between biopsy imaging guidance modality(immediately after the biopsy procedure)
  • To compare the amount of intravenous midazolam used between biopsy imaging guidance modality(immediately after the biopsy procedure)
  • To compare the difference in procedure times between biopsy imaging guidance modality(immediately after the biopsy procedure)

研究者

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

Kenny Lien

Interventional Radiologist

Northwell Health

研究点 (2)

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