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Safety and Diagnostic Yield of Cryobiopsy Versus Forceps Biopsy in Endobronchial Lesions:Assiut University Experience

Evaluation of Safety and Diagnostic Yield of Cryobiopsy Versus Forceps Biopsy in Endobronchial Lesions:Assiut University Experience

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04227743
Enrollment
300
Registered
2020-01-14
Start date
2020-12-01
Completion date
2022-06-30
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endobronchial Lesions

Brief summary

The purpose of this study is to assess the diagnostic yield and show the feasibility and safety of endobronchial biopsies using the flexible cryoprob and to assess the sensitivity of cryobiopsy compared with forceps biopsy

Detailed description

Flexible bronchoscopy is the diagnostic tool of choice to diagnose endobronchial malignancies. It allows inspection and biopsy of any endobronchial abnormalities under direct vision. One of the main goals of diagnostic bronchoscopy, besides visualization of endobronchial abnormalities, is obtaining an adequate tissue samples from the suspicious lesions for cytohistological examination. Several techniques could be applied through the working channel of the flexible bronchoscopy such as forceps biopsy, brush, bronchial washing and transbronchial needle aspiration.Flexible bronchoscopy and the associated tissue sampling techniques are the most widespread procedures in the diagnosis of central lung cancer. Even though the specimens are obtained under direct vision, there is a significant failure rate, which therefore, requires repeated bronchoscopies. Concurrent application of different sampling techniques at bronchoscopy has been shown to improve the yield. Diagnostic bronchoscopy with endobronchial forceps biopsy is primarily practiced in patients with suspected thoracic malignancy and visible endobronchial. The major drawback of the forceps biopsy technique is the relatively small amount of tissue obtained, which is determined by the size of the forceps. Additionally, mechanical compression or crush artefacts from the instrument tip cause alterations of the tissue samples, which affect the quality of the histological analysis. Flexible cryoprobes were introduced as a new tool for bronchoscopic tissue sampling. It is used primarily for debulking and cryoextraction of malignant airway stenosis. With this technique, the sample is collected while still being frozen with the tissue attached on the frozen tip of the probe. By this way, larger tissue samples can be taken from endobronchial lesions and artifact free. The molecular markers are also ions. Tissue samples obtained with cryoprobes are of good quality, size better preserved and well represented.

Interventions

. The cryobiopsy samples will be obtained by advancement of the cryoprobe into the working channel of the bronchoscope to touch the tip of the endobronchial tumor. The freezing time will be approximately 4 seconds. Then, flexible bronchoscope together with tissue sample attached to the tip of the frozen probe will be extracted outside the bronchial tree. The tissue sample will be released from the probe's tip by plunging it into saline at room temperature. FB will be reintroduced after cryobiopsy to evaluate and control the bleeding.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- 1. Exophytic endobronchial tumor (endoscopically visible lesion) 3.Age\>18 years old

Exclusion criteria

\- 1.Patients, who refused to be included in this study or unfit for flexible bronchoscopy 2.patients with hemorrhagic diathesis (prothrombin concentration \<50% and platelet count \<80,000/mm 3). 3.Suspected connection of the lesion to large pulmonary blood vessels as seen on chest computed tomography scan

Design outcomes

Primary

MeasureTime frameDescription
. Assess the diagnostic yield and show the feasibility and safety of endobronchial biopsies using the flexible cryoprobe.1 yearsize (im millimeter) of biopsy from endobronchial lesion obtained by cryoprobe in comparison to those obtained bu flexible forceps

Secondary

MeasureTime frameDescription
complication assessment1 yearPost interventional bleeding classifed into: * No bleeding -Mild bleeding, which was controlled by maintained suction.- * Moderate bleeding, which can be controlled with different interventional techniques e.g local application of saline either normal or cold, adrenalin or balloon tamponade * Severe bleeding, which necessitates ICU admission due to hemodynamic instability and required blood transfusion

Contacts

Primary Contacthadeer sayed khalifa
hadeer_sayed2011@yahoo.com.au01007787691

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026