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

NCT04415255 | Completed

• 2 other identifiers: 18-AKD-15013.07.2018 1.0
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Biopsy

Outcome Measures

Primary Outcomes (1)

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

  the rate of pneumothorax

  1 years

Study Arms (2)

EPABI & IABPI

EXPERIMENTAL

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

Other: EABPI plus IABPI

IABPI-alone

ACTIVE COMPARATOR

intraparenchymal autologous blood patch injection (IABPI)

Other: IABPI-alone

Interventions

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and immediately the remaining autologous blood (\~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.

EPABI & IABPI

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biopsy specimens, immediately the autologous blood (\~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.

IABPI-alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namik Kemal University Medical Faculty Radiology Department

Tekirdağ, 59100, Turkey (Türkiye)

Location

Study Officials

• Yasar Turk

  Namik Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: October 31, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)