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Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors

NCT ID: NCT06531265

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-10-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cryotherapy Effect Bronchial Neoplasms

Keywords

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cryobiopsy cryotherapy endobronchial tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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study group

Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Group Type EXPERIMENTAL

Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Intervention Type PROCEDURE

Bronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation

Interventions

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Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Bronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Hend Mohammed Abdelraheem Esmaeel

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabah Ahmed, PHD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Sohag University

Sohag, , Egypt

Site Status

Sohag University

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-24-06--01PD

Identifier Type: -

Identifier Source: org_study_id