Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy

Namik Kemal University

Status: Completed

Conditions: Lung Biopsy

Treatments: Other: EABPI plus IABPI; Other: IABPI-alone

Study type: Interventional

Funder types: Other

Identifiers

NCT04415255

13.07.2018 1.0 (Other Identifier)

18-AKD-150

Details and patient eligibility

About

The purpose of this study is to evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung biopsy.

Full description

The mechanism of pneumothorax is postulated to be due to the air leakage through the puncture hole when the needle is removed after the biopsy. However, pneumothorax may occur during the needle insertion as the visceral pleura is punctured or during the biopsy procedure before needle removal. Prevent such leakage, the investigators planned to inject autologous blood into the extrapleural space to prevent pneumothorax during needle entry. The extrapleural autologous blood injection (EPABI) is expected to form a space-occupying hematoma pressing on visceral pleura as a sealant. The investigators planned to test the EPABI method in a prospective single-center randomized controlled study design.

Enrollment: 139 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Referred for CT guided biopsy of lung lesion
• Target lesion of any size
• Target lesion located any away from visceral pleura based on the needle path
• Needle path without transgression of a pleural fissure, bleb, or bulla is possible
• Coaxial biopsy technique using Bard 19-Gauge introducer needle
• Needle length =16

Exclusion criteria

• Passage through non-aerated lung or tissue
• More than 1 biopsy on the same side requiring more than 1 pleural puncture
• History of prior ipsilateral lung interventions including:

Chest tube placement Surgery Pleurodesis Radiation treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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139 participants in 2 patient groups

EPABI & IABPI

Experimental group

Description:

extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI)

Treatment:

Other: EABPI plus IABPI

IABPI-alone

Active Comparator group

Description:

intraparenchymal autologous blood patch injection (IABPI)

Treatment:

Other: IABPI-alone