Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541470
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Image-Guided Pleural Needle Biopsy in Pleural Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IMAGE-GUIDED PLEURAL NEEDLE BIOPSY IN THE DIAGNOSIS OF PLEURAL DISEASES ABRAMS NEEDLE OR CUTTING NEEDLE
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent observational studies show that ultrasound guidance generally increases the success of pleural needle biopsies it has been shown that the diagnostic success of needle biopsies is compromised and increased when the presence of pleural fluid is associated with a pleural lesion or pleural thickening or pleural nodular lesions There is no evidence to support a common view on which needle is appropriate in which situation in terms of diagnostic success reliability of benign diagnoses and safety of side effects This study aimed to compare and evaluate the diagnostic yield of the Abrams biopsy needle and the cutting biopsy needle in US-guided pleural needle biopsy to determine which needle is appropriate in which situation As a result of the study the diagnostic yield of the cutting needle was found to be higher in cases with pleural thickening of 1 cm or more and the diagnostic yield of the Abrams needle was found to be higher in patients with pleural thickening of less than 1 cm
Detailed Description:
AIM A significant proportion of the most common exudative pleural effusions approximately 40-50 remain undiagnosed despite repeated thoracentesis and associated diagnostic procedures including cytology Histopathological analysis is often required for definitive diagnosis in these patients For histopathological examination medical thoracoscopy is generally considered to be the most effective and reliable method of obtaining tissue However many studies have shown that image-guidedassisted pleural needle biopsies also have a high diagnostic yield
In recent years respiratory physician-guided thoracic ultrasound TUS has become increasingly popular due to its contribution to managing pleural disease TUS successfully guide pleural needle biopsies Although the observational studies show that ultrasound guidance generally increases the success of needle biopsies it has been shown that the diagnostic success of needle biopsies is compromised and increased when the presence of pleural fluid is associated with a pleural lesion or pleural thickening or pleural nodular lesions There is no evidence to support a common view on which needle is appropriate in which situation in terms of diagnostic success reliability of benign diagnoses and safety of side effects This study aimed to compare and evaluate the diagnostic yield of the Abrams biopsy needle and the cutting biopsy needle in US-guided pleural needle biopsy to determine which needle is appropriate in which situation
METHODS This study was a prospective randomized parallel-group study The Consolidated Standards of Reporting Trials CONSORT guidelines were followed for the study protocol The study was conducted in the Department of Chest Diseases Faculty of Medicine Eskisehir Osmangazi University and Lung and Pleural Cancer Research and Clinical Center from June 2022 to June 2023 The study was approved by the Ethical Committee of Eskisehir Osmangazi University 0303 202201 and the Ministry of Health E-66175679-5140401-800014 and was conducted according to the principles of the Declaration of Helsinki Patients were thoroughly informed before randomization and their written consent was obtained
The study included one hundred and seventy-four patients who met the inclusion criteria Before randomization all patients underwent contrast-enhanced omputed tomography CT
The patients were divided into two groups The cutting needle group group A and the Abrams needle group group B Randomization was performed on the subjects enrolled in the study Block randomization was used with a sequence of 6
Needle biopsies were performed in the pulmonary endoscopy suite The biopsy was performed on the endoscopy table Biopsy was performed using the freehand technique under US guidence First the pleural lesionthickening area the needle could reach was determined as the entry point with the convex probe The needle entry site was marked on the patients chest wall immediately before the biopsy The entry site was then assessed for the safety of the procedure concerning injury to major blood vessels and viscera using the US technique Tissue sampling was performed according to standard cutting and Abrams needle procedures After the biopsy procedures pneumothorax was checked by the US bleeding complications were checked by Doppler US and control thoracentesis was performed if necessary
Patients whose histopathological analyses after needle biopsy did not provide a specific diagnosis and whose diagnosis was reported as fibrinous pleuritis non-specific pleuritis were referred for medical or video thoracoscopy depending on their preference Patients who has fibrinous pleuritis were followed for at least 12 months Patients with recurrent symptoms and clinical or radiological signs of disease were re-evaluated during the follow-up period and invasive diagnostic procedures were repeated as needed Patients who died or were lost to follow-up during this period were excluded from the analyses
Histopathological analysis were performed by the same pathologist in the Eskisehir Osmangazi University Medical Faculty Pathology Department with histologic and immonohistochemical investigations
Statistical analysis
Study data were recorded in a purpose-designed case report form A specific database was created and SPSS version 150 SPSS Inc Chicago Illinois was used for statistical analysis Patient characteristics were reported as means and percentages using descriptive statistics The t-test χ2 test and two-sided Fishers exact test were used to compare the groups The primary endpoint of this study was the determination of sensitivity specificity positive predictive value PPV negative predictive value NPV negative likelihood ratio LR and accuracy values with their confidence intervals CIs and complication rates of both methods concerning the diagnosis of pleural disease These values were determined using MedCalc statistical software version 19116 MedCalc Software Software Ltd Ostend Belgium In the post hoc power analysis the power of the study was calculated as 95 ITT intention-to-treat analysis was performed to show the effect of dropouts in the randomized groups
In recent years respiratory physician-guided thoracic ultrasound TUS has become increasingly popular due to its contribution to managing pleural disease TUS successfully guide pleural needle biopsies Although the observational studies show that ultrasound guidance generally increases the success of needle biopsies it has been shown that the diagnostic success of needle biopsies is compromised and increased when the presence of pleural fluid is associated with a pleural lesion or pleural thickening or pleural nodular lesions There is no evidence to support a common view on which needle is appropriate in which situation in terms of diagnostic success reliability of benign diagnoses and safety of side effects This study aimed to compare and evaluate the diagnostic yield of the Abrams biopsy needle and the cutting biopsy needle in US-guided pleural needle biopsy to determine which needle is appropriate in which situation
METHODS This study was a prospective randomized parallel-group study The Consolidated Standards of Reporting Trials CONSORT guidelines were followed for the study protocol The study was conducted in the Department of Chest Diseases Faculty of Medicine Eskisehir Osmangazi University and Lung and Pleural Cancer Research and Clinical Center from June 2022 to June 2023 The study was approved by the Ethical Committee of Eskisehir Osmangazi University 0303 202201 and the Ministry of Health E-66175679-5140401-800014 and was conducted according to the principles of the Declaration of Helsinki Patients were thoroughly informed before randomization and their written consent was obtained
The study included one hundred and seventy-four patients who met the inclusion criteria Before randomization all patients underwent contrast-enhanced omputed tomography CT
The patients were divided into two groups The cutting needle group group A and the Abrams needle group group B Randomization was performed on the subjects enrolled in the study Block randomization was used with a sequence of 6
Needle biopsies were performed in the pulmonary endoscopy suite The biopsy was performed on the endoscopy table Biopsy was performed using the freehand technique under US guidence First the pleural lesionthickening area the needle could reach was determined as the entry point with the convex probe The needle entry site was marked on the patients chest wall immediately before the biopsy The entry site was then assessed for the safety of the procedure concerning injury to major blood vessels and viscera using the US technique Tissue sampling was performed according to standard cutting and Abrams needle procedures After the biopsy procedures pneumothorax was checked by the US bleeding complications were checked by Doppler US and control thoracentesis was performed if necessary
Patients whose histopathological analyses after needle biopsy did not provide a specific diagnosis and whose diagnosis was reported as fibrinous pleuritis non-specific pleuritis were referred for medical or video thoracoscopy depending on their preference Patients who has fibrinous pleuritis were followed for at least 12 months Patients with recurrent symptoms and clinical or radiological signs of disease were re-evaluated during the follow-up period and invasive diagnostic procedures were repeated as needed Patients who died or were lost to follow-up during this period were excluded from the analyses
Histopathological analysis were performed by the same pathologist in the Eskisehir Osmangazi University Medical Faculty Pathology Department with histologic and immonohistochemical investigations
Statistical analysis
Study data were recorded in a purpose-designed case report form A specific database was created and SPSS version 150 SPSS Inc Chicago Illinois was used for statistical analysis Patient characteristics were reported as means and percentages using descriptive statistics The t-test χ2 test and two-sided Fishers exact test were used to compare the groups The primary endpoint of this study was the determination of sensitivity specificity positive predictive value PPV negative predictive value NPV negative likelihood ratio LR and accuracy values with their confidence intervals CIs and complication rates of both methods concerning the diagnosis of pleural disease These values were determined using MedCalc statistical software version 19116 MedCalc Software Software Ltd Ostend Belgium In the post hoc power analysis the power of the study was calculated as 95 ITT intention-to-treat analysis was performed to show the effect of dropouts in the randomized groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None