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Clinical Trials/NCT06531265
NCT06531265
Completed
Not Applicable

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

Sohag University1 site in 1 country35 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cryotherapy Effect
Sponsor
Sohag University
Enrollment
35
Locations
1
Primary Endpoint
Diagnostic yield
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
October 30, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hend Mohammed Abdelraheem Esmaeel

Associate professor

Sohag University

Eligibility Criteria

Inclusion Criteria

  • patients with radiologically suspected endobronchial masses

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Diagnostic yield

Time Frame: within 10 days

The recording of histopathological diagnosis as revealed by cryobiopsy

Recanalization Success

Time Frame: one day following the procedure

The measurement of degree of airway recanalization through bronchoscopic evaluation

Secondary Outcomes

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

Study Sites (1)

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