EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Not Applicable

• Conditions: Yield of Cryo Biopsy in Lung Cancer; Solitary Pulmonary Nodule
• Interventions: Procedure: Cryo biopsy

• Registration Number: NCT01221493
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-04
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-14
• Last Update Submitted: 2010-10-14
• Study First Posted: 2010-10-15
• Last Update Posted: 2010-10-15
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• coagulopathy
• pulmonary hypertension
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryo biospy	Cryo biopsy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Efficacy	48 h after intervention	Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion

Trial Locations

Locations (1)

Department of Pneumology and Critical Care medicine; 🇩🇪 Heidelberg, BW, Germany