Assessing the ability to obtain a larger tissue sample using a novel Gen cut tool and Radial EBUS for abnormal lung lesions suspected of cancer.

Assessing the ability to obtain a core biopsy from peripheral lung lesions (PPL) using the novel Gen Cut tool with Radial EBUS (R-CORE) - multi-center prospective interventional pilot study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000068268

Acronym

R CORE

Enrollment

Registered

2018-01-17

Start date

2018-02-12

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess the diagnostic ability and safety in obtaining a core biopsy from peripheral lung lesions (PPL) using the novel Gen Cut tool with Radial EBUS. Who is it for? You may be eligible to join this study if you are aged 18 years or over and a have a peripheral lung lesions noted on CT chest/Chest X ray that require a biopsy. Study details Procedure: Informed consent will be taken for the procedure from the patient. Procedure will be performed under conscious sedation or general anaesthesia according to the institution. Once the patient is sedated, the bronchoscope "camera" is introduced via the mouth/nose to the required location. Then a thin USS wire called "Radial EBUS" will be introduced to locate the lesion. Following this the Gen cut biopsy tools will be introduced as the first mode of biopsy. How this study may be beneficial for research/treatment: ThIs study is exploring the new biopsy method (Gen cut) that is safer and can benefit many patients from this safer procedure at their hospital without requiring to transfer to a very specialised centre.

Interventions

Use of the novel GEN cut biopsy tool in addition to usual conventional radial EBUS biopsy tools . GEN cut tool is a blunt ended thin probe of 1.9mm diameter. This has two inwardly placed very small sharp edges that can shear thin slices of tissue with rotation. This tool will be introduced through a guide sheath hence improving the safety of the procedure. The procedure will be performed by a trained bronchoscopist . A bronchoscope is a small flexible tube with a camera at the end of the tube to

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 or older 2. Able to give consent 3. Has a Peripheral lung lesions noted on CT chest/Chest X ray that require a biopsy 4. Lung lesions should be >1.5 cm 5. Lung lesion should be in the outer half of the lung parenchyma

Exclusion criteria

1. Not suitable for flexible bronchoscopy 2. Coagulopathy with INR>1.5 or platelets <100 3. Known pulmonary hypertension with RVSP >40 4. Recent myocardial infarction (within 6 weeks) 5. On anticoagulation or anti-platelets other than aspirin that cannot be stopped for the procedure

Outcome results