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

November 27, 2021 updated by: Nashwa Ahmed Mohammad amin

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Benha University Hospital- Chest Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Procedure: bronchoscpe
bronchoscopic biopsy from lung mass using cryobiopsy and forceps
Other Names:
  • bronchoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative study between Endobronchial Forceps-Biopsy and Cryo-Biopsy in the Diagnosis of bronchogenic carcinoma
Time Frame: comprative , week 40
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nashwa Ahmed Mohammad amin

Investigators

  • Principal Investigator: nashwa ah amin, MD, nashwa ahmed amin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

June 5, 2021

Study Completion (Actual)

September 16, 2021

Study Registration Dates

First Submitted

November 14, 2021

First Submitted That Met QC Criteria

November 27, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 27, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/7/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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