Role of Ultrasound Guided Peripheral Thoracic Tumors
Role of Ultrasound Guided Percutaneous Transthoracic Core Needle Biopsy in Diagnosis of Peripheral Thoracic Tumors
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2020
CompletedFirst Submitted
Initial submission to the registry
October 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedFebruary 5, 2021
February 1, 2021
2 months
October 17, 2020
February 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Value of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal).
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).
8week
Study Arms (1)
ultra sound guided percutaneous core needle biopsy
EXPERIMENTAL60 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
Interventions
Transthoracic ultrasonography: Transthoracic US was done using machine Hitachi 5500 in the Diagnostic Ultrasound Unit - Chest Department- Kasr El-Aini Hospital.on 60 patients that had radiographic evidence of thoracic mass suspected of malignancy
Eligibility Criteria
You may qualify if:
- An acoustic window for the ultrasound beam to penetrate.
- Patients have platelet count more than 100000 and normal prothrombin time.
You may not qualify if:
- Cardio vascular instability.
- Arterio venous malformation or aneurysm.
- Patients with uncontrolled convulsions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Benisuef Unversity
Banī Suwayf, 8776, Egypt
Related Publications (8)
Rivera MP, Detterbeck F, Mehta AC; American College of Chest Physicians. Diagnosis of lung cancer: the guidelines. Chest. 2003 Jan;123(1 Suppl):129S-136S. doi: 10.1378/chest.123.1_suppl.129s.
PMID: 12527572RESULTChira R, Chira A, Mircea PA. Intrathoracic tumors in contact with the chest wall--ultrasonographic and computed tomography comparative evaluation. Med Ultrason. 2012 Jun;14(2):115-9.
PMID: 22675711RESULTBalik M, Plasil P, Waldauf P, Pazout J, Fric M, Otahal M, Pachl J. Ultrasound estimation of volume of pleural fluid in mechanically ventilated patients. Intensive Care Med. 2006 Feb;32(2):318. doi: 10.1007/s00134-005-0024-2. Epub 2006 Jan 24.
PMID: 16432674RESULTDiacon AH, Theron J, Schubert P, Brundyn K, Louw M, Wright CA, Bolliger CT. Ultrasound-assisted transthoracic biopsy: fine-needle aspiration or cutting-needle biopsy? Eur Respir J. 2007 Feb;29(2):357-62. doi: 10.1183/09031936.00077706. Epub 2006 Nov 1.
PMID: 17079257RESULTChira RI, Chira A, Mircea PA, Valean S. Mediastinal masses-transthoracic ultrasonography aspects. Medicine (Baltimore). 2017 Dec;96(49):e9082. doi: 10.1097/MD.0000000000009082.
PMID: 29245326RESULTHafez MR, Sobh ES, Elsawy SB, Abo-Elkheir OI. The usefulness of thoracic ultrasonography in diagnosis and staging of bronchogenic carcinoma. Ultrasound. 2017 Nov;25(4):200-212. doi: 10.1177/1742271X17721264. Epub 2017 Aug 3.
PMID: 29163656RESULTSchubert P, Wright CA, Louw M, Brundyn K, Theron J, Bolliger CT, Diacon AH. Ultrasound-assisted transthoracic biopsy: cells or sections? Diagn Cytopathol. 2005 Oct;33(4):233-7. doi: 10.1002/dc.20342.
PMID: 16138366RESULTYang PC, Luh KT, Chang DB, Wu HD, Yu CJ, Kuo SH. Value of sonography in determining the nature of pleural effusion: analysis of 320 cases. AJR Am J Roentgenol. 1992 Jul;159(1):29-33. doi: 10.2214/ajr.159.1.1609716.
PMID: 1609716RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
maha fathy, MD of chest
beni seuf unversity
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of chest
Study Record Dates
First Submitted
October 17, 2020
First Posted
February 5, 2021
Study Start
September 12, 2020
Primary Completion
November 1, 2020
Study Completion
December 1, 2020
Last Updated
February 5, 2021
Record last verified: 2021-02