Role of Ultrasound Guided Peripheral Thoracic Tumors

Not Applicable

Completed

• Conditions: Thoracic Neoplasms
• Interventions: Diagnostic Test: Ultrasound Guided Peripheral Thoracic Tumors

• Registration Number: NCT04741958
• Lead Sponsor: Beni-Suef University

Brief Summary

The aim of the study was to calculate sensitivity, and accuracy of ultrasound guided percutaneous core needle biopsy in different thoracic tumors (lung, pleural, chest wall and mediastinal).

Detailed Description

Peripheral intrathoracic shadows are common presentation of different diseases of different origin (chest wall, pleura, pulmonary, and mediastinum), they are increasing in numbers including, peripheral lung cancer, tuberculosis, pneumonia, and atelectasis. \[1\] Thoracic masses with wall contact represent a frequent pathology that requires complex imaging studies, and often interventional procedures, in order to reach the complete diagnosis. In most cases, after a thoracic lesion is found on a thoracic X-Ray, the next step is to perform a CT and/or a bronchoscopy exam, but pleural and pulmonary lesions often call for additional investigations.

Therefore, transthoracic ultrasonography (US) permits visualization of these lesions, their structural characterization, while offering suggestive elements for their malignant nature and for the differential diagnosis.

Sonography has the capacity to clarify the nature of opaque lesions such as effusions, atelectasis, masses, and consolidations. Transthoracic ultrasound has received increased interest from chest Physicians in recent years as it has the advantages of bedside availability, absence of radiation, and guided aspiration of fluid-filled areas and solid tumors.

Furthermore US allows percutaneous guided biopsies with lower risks compared with the radiological guiding methods (fluoroscopy and CT). Trransthoracic US can replace other imaging modalities of the chest and guide a variety of diagnostic and therapeutic procedures. Under real time US guidance, the success rate of transthoracic needle aspiration or biopsy (TNB) significantly increases, whereas the risk of complications is greatly reduced.

Study Timeline

• Study Start: 2020-09-12
• Study First Submitted: 2020-10-17
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-04
• Last Update Submitted: 2021-02-04
• Study First Posted: 2021-02-05
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. An acoustic window for the ultrasound beam to penetrate.
2. Patients have platelet count more than 100000 and normal prothrombin time.

Exclusion Criteria

1. Cardio vascular instability.
2. Arterio venous malformation or aneurysm.
3. Patients with uncontrolled convulsions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultra sound guided percutaneous core needle biopsy	Ultrasound Guided Peripheral Thoracic Tumors	60 patients that had radiographic evidence of thoracic mass suspected of malignancy .Twenty masses were in the lung, seventeen lesions were in the pleura, ten masses were in the mediastinum, eleven enlarged palpable lymph nodes, and two masses were in chest wall. The sensitivity, PPV and accuracy for detection of chest tumors in chest wall, mediastinum, lung, and pleura were (100 %) for all, and in LN (88.9, 100 and 90.9 %) respectively. The overall diagnostic performance of sonar guided true cut needle biopsy in diagnosis was 97.78 % sensitivity, 98.18% accuracy, and 100 % PPV

Primary Outcome Measures

Name	Time	Method
Value of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal).	8week	diagnostic performance of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal) in 60 patients that had radiographic evidence of thoracic mass suspected of malignancy by measure sensitivity, accuracy, and Positive predictive values; * True positive result: the tumor is confirmed by a definite histopathologic diagnosis made by Tru-Cut core biopsy; * True negative result: case not diagnosed as a tumor by ultrasound Tru-Cut core biopsy \& this finding was confirmed by another modality for biopsy; * False negative result was considered to have occurred if the tumor wasn't diagnosed by ultrasound guided biopsy, and the tumor was confirmed using other modalities (CT guided, Thoracoscopic, or surgical biopsy).

Trial Locations

Locations (1)

Benisuef Unversity; 🇪🇬 Banī Suwayf, Egypt