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

Not Applicable

Completed

• Conditions: Lung Biopsy
• Interventions: Other: EABPI plus IABPI; Other: IABPI-alone

• Registration Number: NCT04415255
• Lead Sponsor: Namik Kemal University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-10-31
• Study First Submitted: 2020-05-29
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPABI & IABPI	EABPI plus IABPI	extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI)
IABPI-alone	IABPI-alone	intraparenchymal autologous blood patch injection (IABPI)

Primary Outcome Measures

Name	Time	Method
To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)	1 years	the rate of pneumothorax

Trial Locations

Locations (1)

Tekirdag Namik Kemal University Medical Faculty Radiology Department; 🇹🇷 Tekirdag, Turkey