NCT04227743

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Status
unknown

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

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 24, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

January 10, 2020

Last Update Submit

April 21, 2020

Conditions

Endobronchial Lesions

Outcome Measures

Primary Outcomes (1)

  • . Assess the diagnostic yield and show the feasibility and safety of endobronchial biopsies using the flexible cryoprobe.

    size (im millimeter) of biopsy from endobronchial lesion obtained by cryoprobe in comparison to those obtained bu flexible forceps

    1 year

Secondary Outcomes (1)

  • complication assessment

    1 year

Study Arms (1)

patients with endobronchial lesions

EXPERIMENTAL

flexible bronchoscoy will be performed to patients with endobronchial lesions and biopsy from the lesions by forceps and cryoprope will be obtained

Device: cryobiopsy

Interventions

cryobiopsyDEVICE

. 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.

patients with endobronchial lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- 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).
  • Suspected connection of the lesion to large pulmonary blood vessels as seen on chest computed tomography scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Dobler CC, Crawford AB. Bronchoscopic diagnosis of endoscopically visible lung malignancies: should cytological examinations be carried out routinely? Intern Med J. 2009 Dec;39(12):806-11. doi: 10.1111/j.1445-5994.2008.01882.x.

    PMID: 20233241BACKGROUND

  • Rivera MP, Detterbeck F, Mehta AC; American College of Chest Physicians. Diagnosis of lung cancer: the guidelines. Chest. 2003 Jan;123(1 Suppl):129S-136S. doi: 10.1378/chest.123.1_suppl.129s.

    PMID: 12527572BACKGROUND

  • Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s.

    PMID: 12527571BACKGROUND

  • Hetzel M, Hetzel J, Schumann C, Marx N, Babiak A. Cryorecanalization: a new approach for the immediate management of acute airway obstruction. J Thorac Cardiovasc Surg. 2004 May;127(5):1427-31. doi: 10.1016/j.jtcvs.2003.12.032.

    PMID: 15116003BACKGROUND

  • Schumann C, Hetzel J, Babiak AJ, Merk T, Wibmer T, Moller P, Lepper PM, Hetzel M. Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions. J Thorac Cardiovasc Surg. 2010 Aug;140(2):417-21. doi: 10.1016/j.jtcvs.2009.12.028. Epub 2010 Mar 11.

    PMID: 20226474BACKGROUND

  • Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.

    PMID: 19246874BACKGROUND

  • Aktas Z, Gunay E, Hoca NT, Yilmaz A, Demirag F, Gunay S, Sipit T, Kurt EB. Endobronchial cryobiopsy or forceps biopsy for lung cancer diagnosis. Ann Thorac Med. 2010 Oct;5(4):242-6. doi: 10.4103/1817-1737.69117.

    PMID: 20981186BACKGROUND

Central Study Contacts

hadeer sayed khalifa

CONTACT

01007787691hadeer_sayed2011@yahoo.com.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

December 1, 2020

Primary Completion

November 30, 2021

Study Completion

June 30, 2022

Last Updated

April 24, 2020

Record last verified: 2020-01