Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

Mayo Clinic30 enrolled

Overview

This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bronchi--Diseases Lung Diseases, Obstructive Lesions Mass

Interventions

Cryoprobe biopsyDEVICE

A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue

Forceps biopsyPROCEDURE

Biopsy forceps used to collect tissue

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy. Lesion Criteria: \- Pulmonary nodules of 8-50mm in largest dimension. Exclusion Criteria: * Patients with known bleeding diathesis; Platelet count \< 50,000. * Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable). * Inability or unwillingness to give informed consent. * Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment. * Pulmonary hypertension, defined as a right ventricular systolic pressure \> 50 mmHg. * Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent. * International Normalized Ratio (INR) \< 1.5. * Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Locations (1)

Mayo Clinic Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Ability to Successfully Obtain Sample

Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis

Time frame: Baseline

Secondary Outcomes

Duration of Biopsy Procedure

Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens.

Time frame: Biopsy procedure, approximately 3 hours

Freezing Time for Cryoprobe Biopsies

Total freezing time for cryoprobe biopsies, measured in seconds

Time frame: Biopsy procedure, approximately 60 seconds

Number of Successful Biopsy Attempts

One attempt is defined as insertion of the biopsy probe into the robotic sheath, activation/employment of the biopsy mechanism at the target site and retrieval via the robotic sheath. A biopsy attempt is successful if a tissue sample that is considered by the bronchoscopist to be adequate for further pathological analysis can be retrieved.

Time frame: Biopsy procedure, approximately 3 hours

Histological Accessibility Grade

Pathologic description ranging from insufficient to diagnostic material

Time frame: Pathology review, approximately 1 day

Histological Diagnostic Yield

Defined as the ability of the pathologist to make a diagnostic statement based on the histological analysis of the obtained tissue samples. Graded 1-4 with 1 being insufficient tissue and 4 being diagnostic material.

Time frame: Pathology review, approximately 1 day

Total Histological Area

Data from ClinicalTrials.gov

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