NCT05151419

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

November 14, 2021

Last Update Submit

November 27, 2021

Conditions

Keywords

bronchoscope, cryo-biopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

bronchoscope ,forceps,cryo-biopsy

OTHER

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

Interventions

bronchoscpePROCEDURE

bronchoscopic biopsy from lung mass using cryobiopsy and forceps

Also known as: bronchoscope
bronchoscope ,forceps,cryo-biopsy

Eligibility Criteria

Age47 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospital- Chest Department

Cairo, Egypt

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopes

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • nashwa ah amin, MD

    nashwa ahmed amin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nashwa Ahmed Mohammad amin

Study Record Dates

First Submitted

November 14, 2021

First Posted

December 9, 2021

Study Start

July 21, 2020

Primary Completion

June 5, 2021

Study Completion

September 16, 2021

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations