NCT02739126

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

February 19, 2016

Last Update Submit

April 10, 2016

Conditions

Pulmonary Parenchymal Lesions

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (1)

  • Comparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath.

    A blinded pathologist will assess all samples from the thick USS arm and all samples from the thin USS arm separately and come to a conclusion as 1. To what biopsies give a diagnosis of malignancy and 2. Will decide what is the best sample in comparing all samples from both arms defined as " the highest number of malignant cells/hpf".

    18 months

Secondary Outcomes (2)

  • Suitability of the biopsy samples from each arm to perform EGFR mutation testing.

    18 months

  • Compare the procedure related bleeding and pneumothorax rates between the two arms.

    18 months

Study Arms (2)

Thick USS (1.7mm) with use of additional aspiration needle

ACTIVE COMPARATOR
Procedure: Radial EBUS biopsyDevice: Types of Radial Ultrasound probes

Thin USS (1.4mm)

ACTIVE COMPARATOR
Procedure: Radial EBUS biopsyDevice: Types of Radial Ultrasound probes

Interventions

Radial EBUS biopsyPROCEDURE

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

Thick USS (1.7mm) with use of additional aspiration needleThin USS (1.4mm)
Types of Radial Ultrasound probesDEVICE

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.

Thick USS (1.7mm) with use of additional aspiration needleThin USS (1.4mm)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient referred for R-EBUS as per routine management.
  • Patient judged to be medically stable to give consent for this study.

You may not qualify if:

  • INR\>1.5
  • Platelets\<150.
  • Hb\> 80g/l
  • Liver function tests (AST/ALT) \<2 times upper limit of normal
  • Neutrophil count \>1.0
  • EGFR \>30ml/kg/min
  • On anticoagulation, that cannot be withheld for the procedure, due to medical reasons (e.g. On-clopidogrel with recent drug-eluting stent placement.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Middlemore Hospital, Counties Manakau District Health Board

Auckland, Auckland, 2025, New Zealand

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Physician

Study Record Dates

First Submitted

February 19, 2016

First Posted

April 15, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 15, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)