EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Heidelberg University30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Yield of Cryo Biopsy in Lung Cancer Solitary Pulmonary Nodule

Interventions

Cryo biopsyPROCEDURE

Cryoprobe, Erbe Company

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * solitary pulmonary nodule \< 4 cm * no endobronchial lesion * indication for bronchoscopy Exclusion Criteria: * coagulopathy * pulmonary hypertension * pregnancy

Locations (1)

Department of Pneumology and Critical Care medicine

Heidelberg, Baden-Wurttemberg, Germany

RECRUITING

Outcomes

Primary Outcomes

Safety

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 Outcomes

Efficacy

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

Time frame: 48 h after intervention

Central Contacts

Felix JF Herth, MD, PhD

CONTACT

+49-6221 396 felix.herth@thoraxklinik-heidelberg.de

Ralf Eberhardt, MD

CONTACT

+49 6221-396 ralf.eberhardt@thoraxklinik-heidelberg.de

Data from ClinicalTrials.gov

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