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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Biopsy
• Intervention / Treatment: Other: EABPI plus IABPI; Other: IABPI-alone

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 Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tekirdag, Turkey, 59100
    • Tekirdag Namik Kemal University Medical Faculty Radiology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EPABI & IABPI; extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI)	Other: EABPI plus IABPI; 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.
ACTIVE_COMPARATOR: IABPI-alone; intraparenchymal autologous blood patch injection (IABPI)	Other: IABPI-alone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)	the rate of pneumothorax	1 years

Collaborators and Investigators

• Sponsor: Namik Kemal University
• Investigators: Principal Investigator: Yasar Turk, Tekirdag Namik Kemal University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18-AKD-150; 13.07.2018 1.0 (OTHER: Tekirdağ NKU Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No