MedTrace Logo

Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe.

NCT02739126 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-04-15

No results posted yet for this study

Summary

Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous origin is of utmost importance. Due to it's markedly favourable safety profile, a bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success rate), is sub-optimal.

There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be advanced more peripherally to obtain a biopsy.

Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield.

In this study, investigators compare these two types of probes in the ability to diagnose a PPL.

The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too small to accommodate an aspiration needle)

Conditions

  • Pulmonary Parenchymal Lesions

Interventions

PROCEDURE

Radial EBUS biopsy

Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.

DEVICE

Types of Radial Ultrasound probes

The Radial USS probe comes in two sizes. A thick USS probe that is 1.7mm and the thin USS is 1.4mm in diameter.

Sponsors & Collaborators

  • Middlemore Hospital, New Zealand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02739126 on ClinicalTrials.gov