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临床试验/NCT06531265
NCT06531265已完成不适用

Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors: A Prospective Study

Sohag University3 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年7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
35
试验地点
3
主要终点
Diagnostic yield

研究概览

简要总结

This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors.

详细描述

Novel flexible cryoprobes were introduced for tissue sampling during bronchoscopy. Employing this approach, the sample is collected when frozen, with the tissue attached to the frozen end of the probe. This approach enables the retrieval of larger tissue samples from endobronchial lesionsEndobronchial cryotherapy is employed to treat individuals with obstructive central bronchial lung cancers. It has been demonstrated to effectively recanalize obstructed respiratory passages, alleviate symptoms, and improve the quality of life for patients in advanced stagesThis study aimed to assess the effectiveness and safety of using bronchoscopic cryotechniques for diagnosing and treating endobronchial malignancies.

研究设计

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

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

  • patients with radiologically suspected endobronchial masses

排除标准

  • Patients with contraindications to bronchoscopy.
  • uncorrected coagulopathy (if the international normalized ratio (INR) is more than 1.5).
  • severe refractory hypoxemia (even after administering the highest possible dose of oxygen, the partial pressure of oxygen ("PaO2") stays below 70 mm Hg.
  • hypoventilation with hypercapnia (type 2 respiratory failure).
  • severe pulmonary hypertension > 55 mmHg by echocardiography.
  • hemodynamic instability.

结局指标

主要结局

Diagnostic yield

时间窗: within 10 days

The recording of histopathological diagnosis as revealed by cryobiopsy

Recanalization Success

时间窗: one day following the procedure

The measurement of degree of airway recanalization through bronchoscopic evaluation

次要结局

  • Degree of dyspnea improvement after the procedure(2 weeks after the procedure)

研究者

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

Hend Mohammed Abdelraheem Esmaeel

Associate professor

Sohag University

研究点 (3)

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