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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05151419
• Other study ID #: 21/7/2020
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: September 16, 2021

Study information

• Verified date: November 2021
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 16, 2021
• Est. primary completion date: June 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 47 Years to 88 Years

Eligibility

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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Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• bronchoscpe
bronchoscopic biopsy from lung mass using cryobiopsy and forceps

Locations

Country	Name	City	State
Egypt	Benha University Hospital- Chest Department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nashwa Ahmed Mohammad amin

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	comprative , week 40