EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Solitary Pulmonary Nodule Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01221493
• Other study ID #: S-320
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2010
• Last updated: October 14, 2010
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Heidelberg University
• Contact: Felix JF Herth, MD, PhD
• Phone: +49-6221 396
• Email: felix.herth[@]thoraxklinik-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• solitary pulmonary nodule < 4 cm

• no endobronchial lesion

• indication for bronchoscopy

Exclusion Criteria:

• coagulopathy

• pulmonary hypertension

• pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule
• Yield of Cryo Biopsy in Lung Cancer

Intervention

Procedure:
• Cryo biopsy
Cryoprobe, Erbe Company

Locations

Country	Name	City	State
Germany	Department of Pneumology and Critical Care medicine	Heidelberg	BW

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication	24 h after intervention	Yes
Secondary	Efficacy	Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion	48 h after intervention	No