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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

bronchoscpe

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring bronchoscope, cryo-biopsy

Eligibility Criteria

47 Years - 88 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Benha University Hospital- Chest Department

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

bronchoscope ,forceps,cryo-biopsy

Arm Description

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

Outcomes

Primary Outcome Measures

Comparative study between Endobronchial Forceps-Biopsy and Cryo-Biopsy in the Diagnosis of bronchogenic carcinoma

The comparison between groups regarding qualitative data was done by using Chi-square test and/or Fisher exact test when the expected count in any cell found less than 5.at week 40

Secondary Outcome Measures

Full Information

NCT ID

NCT05151419

First Posted

November 14, 2021

Last Updated

November 27, 2021

Sponsor

Nashwa Ahmed Mohammad amin

1. Study Identification

Unique Protocol Identification Number

NCT05151419

Brief Title

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

Official Title

Comparative Study Between Endobronchial Forceps-Biopsy and Cryo-Biopsy in the Diagnosis of Bronchogenic Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

July 21, 2020 (Actual)

Primary Completion Date

June 5, 2021 (Actual)

Study Completion Date

September 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nashwa Ahmed Mohammad amin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

bronchoscope, cryo-biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bronchoscope ,forceps,cryo-biopsy

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

bronchoscpe

Other Intervention Name(s)

bronchoscope

Intervention Description

bronchoscopic biopsy from lung mass using cryobiopsy and forceps

Primary Outcome Measure Information:

Title

Comparative study between Endobronchial Forceps-Biopsy and Cryo-Biopsy in the Diagnosis of bronchogenic carcinoma

Description

The comparison between groups regarding qualitative data was done by using Chi-square test and/or Fisher exact test when the expected count in any cell found less than 5.at week 40

Time Frame

comprative , week 40

10. Eligibility

Sex

All

Minimum Age & Unit of Time

47 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

nashwa ah amin, MD

Organizational Affiliation

nashwa ahmed amin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Benha University Hospital- Chest Department

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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