Идёт набор NCT06340178

CT-guided Lung Biopsy Risk Optimization Method

Без фазы С лечением Pneumothorax Biopsy, Needle Risk Factors Radiology, Interventional

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Fluid application during ct-guided lung biopsy.
Кому может быть актуально: Состояния в реестре: Pneumothorax, Biopsy, Needle, Risk Factors, Radiology, Interventional. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure

Обзор

The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.

Подробное описание

Study participants with written consent and the percutaneous, CT-guided lung biopsy already regularly indicated by the referring doctors (e.g., oncology) will be part of this study and will be randomized directly before the intervention. After randomization, the intervention is performed by Interventional Radiology, either with or without prior fluid administration into the pleural space. Three samples are taken using either an 18G or 20G coaxial needle, and any complications are treated according to the clinical standard. The lung biopsy will be only performed if clinically indicated and is not a study-specific intervention; data about the lung biopsy, like internal DICOM images of them retrieved from Inselspital's Picture Archiving and Communication System (PACS), laboratory results, and clinical information are retrieved from RIS (radiological information system) and iPDOS® and KISS by Epic® (electronic medical record) and the associated histopathological findings from the Institute of Pathology, University of Bern, will be analyzed.

Вмешательства

Процедура Fluid application during ct-guided lung biopsy
Injection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site

Первичные конечные точки

Number of patients with pneumothorax [Срок оценки: Immediate after biopsy, expected to be on average 5 minutes]

Вторичные конечные точки (3)

Number of patients with bleeding [Срок оценки: Immediate after biopsy, expected to be on average 5 minutes]
Number of patients with chest tube placement [Срок оценки: Immediate after biopsy, expected to be on average 5 minutes]
Number of patients with air embolism [Срок оценки: Immediate after biopsy, expected to be on average 5 minutes]

Критерии участия

Критерии включения

Ability to provide informed consent (knowledge of project languages), >18 years.
Indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or Status after unsuccessful transbronchial biopsy
Indication for biopsy given by referring specialist (in patients).