EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

• Sponsor: Heidelberg University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01221493
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Yield of Cryo Biopsy in Lung Cancer; Solitary Pulmonary Nodule	Procedure: Cryo biopsy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Apr 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cryo biospy	Procedure: Cryo biopsy; Cryoprobe, Erbe Company; Other Names: Cryo biopsy probe 20416-032, ERBE company, Germany

Outcome Measures

Primary Outcome Measures

1. Safety [24 h after intervention]

   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

1. Efficacy [48 h after intervention]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• solitary pulmonary nodule < 4 cm

• no endobronchial lesion

• indication for bronchoscopy

Exclusion Criteria:

• coagulopathy

• pulmonary hypertension

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pneumology and Critical Care medicine	Heidelberg	BW	Germany	69190

Sponsors and Collaborators

• Heidelberg University

Investigators

• Principal Investigator: Felix JF Herth, MD, PhD, Thoraxklinik, Universityof Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT01221493
• Other Study ID Numbers: S-320
• First Posted: Oct 15, 2010
• Last Update Posted: Oct 15, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: solitary pulmonary nodules; transbronchial lung biopsy; endobronchial ultrasound
• Additional relevant MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Study Results

No Results Posted as of Oct 15, 2010