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Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531265
Enrollment
35
Registered
2024-07-31
Start date
2019-07-01
Completion date
2022-10-30
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Neoplasms, Cryotherapy Effect

Keywords

cryobiopsy, cryotherapy, endobronchial tumors

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.

Interventions

PROCEDUREEndobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Bronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation

Sponsors

Cairo University
CollaboratorOTHER
Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic yieldwithin 10 daysThe recording of histopathological diagnosis as revealed by cryobiopsy
Recanalization Successone day following the procedureThe measurement of degree of airway recanalization through bronchoscopic evaluation

Secondary

MeasureTime frameDescription
Degree of dyspnea improvement after the procedure2 weeks after the procedureMeasurement of degree of dyspnea before and after the procedure using Modified medical research counsil scale for dyspnea (mMRC scale)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026