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EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

NCT ID: NCT01221493

Last Updated: 2010-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions

Detailed Description

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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.

Conditions

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Yield of Cryo Biopsy in Lung Cancer Solitary Pulmonary Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cryo biospy

Group Type EXPERIMENTAL

Cryo biopsy

Intervention Type PROCEDURE

Cryoprobe, Erbe Company

Interventions

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Cryo biopsy

Cryoprobe, Erbe Company

Intervention Type PROCEDURE

Other Intervention Names

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Cryo biopsy probe 20416-032, ERBE company, Germany

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* coagulopathy
* pulmonary hypertension
* pregnancy
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Thoraxklinik, University of Heidelberg

Principal Investigators

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Felix JF Herth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thoraxklinik, Universityof Heidelberg

Locations

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Department of Pneumology and Critical Care medicine

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Felix JF Herth, MD, PhD

Role: CONTACT

[email protected]
+49-6221 396 ext. 1200

Ralf Eberhardt, MD

Role: CONTACT

[email protected]
+49 6221-396 ext. 8204

Facility Contacts

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Felix JF Herth, MD, PhD

Role: primary

[email protected]
+49 6221 396 ext. 1200

References

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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.

Reference Type BACKGROUND
PMID: 20802352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20477337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19648733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20203535 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23900983 (View on PubMed)

Other Identifiers

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S-320

Identifier Type: -

Identifier Source: org_study_id