Skip to main content
OpenTrials
Completed

NCT Number: NCT06531265

Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cryotherapy Effect Bronchial Diseases Bronchial Neoplasms Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University, Sohag, Egypt

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Procedure

Bronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation

Primary outcomes

  1. Diagnostic yield

    Time frame: within 10 days

    The recording of histopathological diagnosis as revealed by cryobiopsy

  2. Recanalization Success

    Time frame: one day following the procedure

    The measurement of degree of airway recanalization through bronchoscopic evaluation

Secondary outcomes

  1. Degree of dyspnea improvement after the procedure

    Time frame: 2 weeks after the procedure

    Measurement of degree of dyspnea before and after the procedure using Modified medical research counsil scale for dyspnea (mMRC scale)

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.