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临床试验/NCT04553809
NCT04553809已完成不适用

The Efficacy of Combining Endoscopic Modalities for the Diagnosis of Solitary Pulmonary Lesions

Amanda Dandanell Juul2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月12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
200
试验地点
2
主要终点
Total diagnostic yield

研究概览

简要总结

Lung cancer is the primary cause of cancer related deaths in Denmark. In order to improve the prognosis diagnosis in earlier stages are needed. This will however require improved sampling techniques from very small lung lesions.

One method involves the use of a radial ultrasound probe inserted in the working channel of the bronchoscope, to more accurately identify the lung lesions before sampling them (rEBUS). The other method involves the use of electromagnetic navigation bronchoscopy (ENB) to guide the operator to the lung lesion.

This study aims to determine whether a combination of rEBUS and ENB is superior to ENB alone in biopsy sampling. The study will be conducted as a non-blinded RCT. Furthermore, we will make an estimate of the hospital costs of the entire diagnostic work up for lung cancer when combining ENB and rEBUS compared to ENB alone.

详细描述

Background:

Despite recent years' improvement regarding the treatment of lung cancer, it remains the leading cause of cancer deaths in Denmark. This is partly due to many patients being diagnosed in an advanced stage limiting the possibilities of curative treatment. Much attention has therefore been aimed at developing tools for early identification of patients with possible lung cancer . Screening or easy access to CT of the chest may help to identify patients with possible early stage lung cancer. Performing biopsies of small lung lesions in a safe manner without inexpedient complications, however, is an ongoing diagnostic challenge especially for the increasing elderly patient population and patients with decreased lung function. If patients are to benefit from an improved identification of possible early stage lung cancer, it is necessary to also further improve the methods for obtaining biopsies in this patient population in order to decrease the morbidity during the diagnostic work-up and to prepare the patients for treatment in a secure manner.

Current methods for performing biopsies of small lung lesions are transthoracic, endoscopic or surgical. When compared to surgery, the endoscopic methods have the advantages of being easily accessible, cheap, safe with a very low risk of complications, and have limited patient discomfort following the procedure. The major drawback is the diagnostic yield still being significantly lower than surgery.

In recent years, two methods have been developed which seem to improve the diagnostic yield of bronchoscopy for diagnosing peripheral lung lesions. The rationale behind both techniques is to improve identification of the lung lesions prior to performing the biopsies and thereby improving the chance of obtaining representative tissue samples. One method involves the use of a radial ultrasound probe inserted in the working channel of the bronchoscope, which enables the proceduralist to perform radial endobronchial ultrasound (rEBUS) to more accurately identify the lung lesions before sampling them. The other method involves the use of electromagnetic navigation bronchoscopy (ENB) to guide the operator to the lung lesion. One small randomised clinical trial has indicated that the diagnostic yield can be further improved by a multimodal approach, which combines both rEBUS and ENB in the same procedure. The drawbacks of such a combination are however increased costs and procedure time, thus limiting the number of procedures which can be performed within a given time frame.

This PhD thesis aims to determine whether a combination of rEBUS and ENB is superior to ENB alone in patients with suspected lung cancer due to a peripheral lung lesion as well as an estimate of the hospital costs of the entire diagnostic work up for lung cancer when combining ENB and rEBUS as compared to ENB alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Examination for lung cancer
  • Peripheral lung lesion or lung nodule surrounded by normal lung parenchyma
  • Written and orally informed consent

排除标准

  • Patient has medical devices in which ENB is contraindicated (e.g. implanted pacemaker or defibrillator)
  • Pregnancy

结局指标

主要结局

Total diagnostic yield

时间窗: 6 months

Total diagnostic yield, being defined as a tissue biopsy allowing a definite diagnosis of either a malignant or benign condition in the lung in proportion to the total number of procedures performed.

次要结局

  • Non-malignant diagnostic yield(6 months)
  • Severe complications(1 week)
  • Malignant diagnostic yield(6 months)
  • Complications(1 week)
  • Procedure costs(2 years)
  • Ready to treat(7 months)
  • Discomfort(2 weeks)
  • Procedure time(1 week)
  • Patient satisfaction(2 weeks)
  • Entire work-up costs(2 years)

研究者

发起方
Amanda Dandanell Juul
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amanda Dandanell Juul

MD, PhD student

University of Southern Denmark

研究点 (2)

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