Clinical trial NCT05151419: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: bronchoscope, cryo-biopsy
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 47
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

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Primary outcomes:
measure: Comparative study between Endobronchial Forceps-Biopsy and Cryo-Biopsy in the Diagnosis of bronchogenic carcinoma
timeFrame: comprative , week 40
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Benha University Hospital- Chest Department
Study officials:
affiliation: nashwa ahmed amin
name: nashwa ah amin, MD
role: PRINCIPAL_INVESTIGATOR
References: