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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Biopsy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tekirdag Namik Kemal University Medical Faculty Radiology Department

Tekirdağ, 59100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EABPI plus IABPI

Other

If the patient was assigned to EPABI plus IABPI, while the extrapleural space was reached, ~ 15 ml of autologous blood was injected at the extrapleural space through the coaxial needle. Then the central stylet was reinserted and the coaxial needle was advanced into the lung parenchyma with a single puncture. The needle was stopped inside the proximal part of the target and the center needle was removed. A 20-G/16 cm fully-automated biopsy needle was introduced through the 19-G/13.8 cm coaxial needle and specimens were identically obtained. After specimens were collected, the biopsy needle was removed, and immediately the remaining autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.

IABPI-alone

Other

If the patient was assigned to IABPI-alone, after collecting the biopsy specimens, immediately the autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.

Primary outcomes

To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)

Time frame: 1 years

the rate of pneumothorax

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study title

Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy and Its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-center, Prospective, Randomized, and Controlled Clinical Trial

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jun 4, 2020
Registry last updated: Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed