Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors

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

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

Study Overview

• Status: Completed
• Conditions: Bronchial Neoplasms; Cryotherapy Effect
• Intervention / Treatment: Procedure: Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82425
    • Sohag University
  • Sohag, Egypt, 82524
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy	Procedure: Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy; Bronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of dyspnea improvement after the procedure	Measurement of degree of dyspnea before and after the procedure using Modified medical research counsil scale for dyspnea (mMRC scale)	2 weeks after the procedure

Collaborators and Investigators

• Sponsor: Sohag University
• Collaborators: Cairo University
• Investigators: Study Director: Sabah Ahmed, PHD, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: cryotherapy; cryobiopsy; endobronchial tumors
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Bronchial Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Bronchial Neoplasms
• Other Study ID Numbers: Soh-Med-24-06--01PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No