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EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Primary Purpose

Yield of Cryo Biopsy in Lung Cancer, Solitary Pulmonary Nodule

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cryo biopsy
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Yield of Cryo Biopsy in Lung Cancer focused on measuring solitary pulmonary nodules, transbronchial lung biopsy, endobronchial ultrasound

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • solitary pulmonary nodule < 4 cm
  • no endobronchial lesion
  • indication for bronchoscopy

Exclusion Criteria:

  • coagulopathy
  • pulmonary hypertension
  • pregnancy

Sites / Locations

  • Department of Pneumology and Critical Care medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryo biospy

Arm Description

Outcomes

Primary Outcome Measures

Safety
Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication

Secondary Outcome Measures

Efficacy
Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion

Full Information

First Posted
October 14, 2010
Last Updated
October 14, 2010
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01221493
Brief Title
EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions
Detailed Description
Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy. Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yield of Cryo Biopsy in Lung Cancer, Solitary Pulmonary Nodule
Keywords
solitary pulmonary nodules, transbronchial lung biopsy, endobronchial ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryo biospy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cryo biopsy
Other Intervention Name(s)
Cryo biopsy probe 20416-032, ERBE company, Germany
Intervention Description
Cryoprobe, Erbe Company
Primary Outcome Measure Information:
Title
Safety
Description
Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication
Time Frame
24 h after intervention
Secondary Outcome Measure Information:
Title
Efficacy
Description
Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion
Time Frame
48 h after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: solitary pulmonary nodule < 4 cm no endobronchial lesion indication for bronchoscopy Exclusion Criteria: coagulopathy pulmonary hypertension pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix JF Herth, MD, PhD
Phone
+49-6221 396
Ext
1200
Email
felix.herth@thoraxklinik-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ralf Eberhardt, MD
Phone
+49 6221-396
Ext
8204
Email
ralf.eberhardt@thoraxklinik-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD, PhD
Organizational Affiliation
Thoraxklinik, Universityof Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pneumology and Critical Care medicine
City
Heidelberg
State/Province
BW
ZIP/Postal Code
69190
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD, PhD
Phone
+49 6221 396
Ext
1200
Email
felix.herth@thoraxklinik-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD, Phd
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20802352
Citation
Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.
Results Reference
background
PubMed Identifier
20477337
Citation
Eberhardt R, Gompelmann D, Herth FJ. Electromagnetic navigation in lung cancer: research update. Expert Rev Respir Med. 2009 Oct;3(5):469-73. doi: 10.1586/ers.09.36.
Results Reference
background
PubMed Identifier
19648733
Citation
Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60. doi: 10.1159/000232394. Epub 2009 Jul 31.
Results Reference
background
PubMed Identifier
20203535
Citation
Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': bronchoscopic-guided therapy of peripheral lung lesions. Respiration. 2010;79(4):265-73. doi: 10.1159/000284015. Epub 2010 Feb 10.
Results Reference
background
PubMed Identifier
23900983
Citation
Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.
Results Reference
derived

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EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

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