Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors

Not Applicable

Completed

• Conditions: Cryotherapy Effect; Bronchial Neoplasms
• Interventions: Procedure: Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

• Registration Number: NCT06531265
• Lead Sponsor: Sohag University

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy	Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	within 10 days	The recording of histopathological diagnosis as revealed by cryobiopsy
Recanalization Success	one day following the procedure	The measurement of degree of airway recanalization through bronchoscopic evaluation

Secondary Outcome Measures

Name	Time	Method
Degree of dyspnea improvement after the procedure	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)

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Egypt