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Forceps Biopsy Versus Cryo-biopsy in the Diagnosis of Lung Cancer

NCT ID: NCT05151419

Last Updated: 2021-12-09

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2021-09-16

Brief Summary

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This study was comprised of 30 patients who were scheduled for a diagnostic bronchoscopy due to a suspicion of lung cancer in order to obtain tissue samples for a final diagnosis , four biopsies were taken by each of cryobiopsy and forceps biopsy , to evaluate and compare the diagnostic yield of endobronchial cryobiopsy and forceps biopsy in the diagnosis of lung cancer .

Detailed Description

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Diagnostic bronchoscopic interventions are used to evaluate and tissue sample from endobronchial lesions utilising variety of devices that can be delivered through the operative channel of a fibrio-optic bronchoscope.

All of the procedures were carried out with 2% lidocaine instillation and midazolam IV sedation All patients signed a written informed consent form for bronchoscopy and tissue sampling with forceps and a cryoprobe.between August 2020 and June 2021. All interventions were performed in the bronchoscopy unit of the Chest Medicine Department at Benha university Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 23. The quantitative data with parametric distribution were presented as mean, standard deviations and ranges.

Conditions

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Lung Cancer

Keywords

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bronchoscope, cryo-biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A total number of 30 participants were enrolled in our study. These individuals had a diagnostic bronchoscopy because they had a suspicion of lung cancer and needed tissue samples to confirm the diagnosis. All of the procedures were carried out with 2% lidocaine instillation and midazolam IV sedation
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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bronchoscope ,forceps,cryo-biopsy

biopies were taken from the lung mass using forceps and cryo-biopsy to evalute diagnostic yield of cryo-biosy versus forceps in the diagnosis of lung cancer

Group Type OTHER

bronchoscpe

Intervention Type PROCEDURE

bronchoscopic biopsy from lung mass using cryobiopsy and forceps

Interventions

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bronchoscpe

bronchoscopic biopsy from lung mass using cryobiopsy and forceps

Intervention Type PROCEDURE

Other Intervention Names

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bronchoscope

Eligibility Criteria

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Inclusion Criteria

* severe uncorrected hypoxemia despite supplemental oxygen treatment
* unstable angina
* uncontrolled arrhythmias,
* severe hypercarbia,
* unstable cervical spine.
* Coagulopathy that cannot be reversed
* Chronic obstructive pulmonary disease (COPD) exacerbation
* Severe Illness
* old age
* malnutrition
* Patient who refused to have a bronchoscopy performed

Exclusion Criteria

Patients' histories, including age, sex, and smoking status, were documented for all participants in the trial Clinical examination and medical history Complete blood count, serum creatinine, liver enzymes, INR, bleeding time, and clotting time are all routine laboratory tests Plain chest X-ray and chest computed tomography were used in the radiological workup\* Arterial blood gas on room air. bronchoscopy and biopsy taking with forceps and cryobiopsy

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Minimum Eligible Age

47 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nashwa Ahmed Mohammad amin

OTHER

Sponsor Role lead

Responsible Party

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Nashwa Ahmed Mohammad amin

Nashwa Ahmed Mohammad amin

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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nashwa ah amin, MD

Role: PRINCIPAL_INVESTIGATOR

nashwa ahmed amin

Locations

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Benha University Hospital- Chest Department

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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21/7/2020

Identifier Type: -

Identifier Source: org_study_id