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Role of Ultrasound Guided Peripheral Thoracic Tumors

Primary Purpose

Thoracic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound Guided Peripheral Thoracic Tumors
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thoracic Neoplasms focused on measuring Ultrasound; ., Chest; Diseases, Core needle biopsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Benisuef Unversity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultra sound guided percutaneous core needle biopsy

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 17, 2020
Last Updated
February 4, 2021
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04741958
Brief Title
Role of Ultrasound Guided Peripheral Thoracic Tumors
Official Title
Role of Ultrasound Guided Percutaneous Transthoracic Core Needle Biopsy in Diagnosis of Peripheral Thoracic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Neoplasms
Keywords
Ultrasound; ., Chest; Diseases, Core needle biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The current study is a case series study conducted on 60 patients that had radiographic evidence of thoracic mass suspected of malignancy
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultra sound guided percutaneous core needle biopsy
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound Guided Peripheral Thoracic Tumors
Intervention Description
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
Primary Outcome Measure Information:
Title
Value of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal).
Description
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).
Time Frame
8week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An acoustic window for the ultrasound beam to penetrate. Patients have platelet count more than 100000 and normal prothrombin time. Exclusion Criteria: Cardio vascular instability. Arterio venous malformation or aneurysm. Patients with uncontrolled convulsions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maha fathy, MD of chest
Organizational Affiliation
beni seuf unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benisuef Unversity
City
Banī Suwayf
ZIP/Postal Code
8776
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12527572
Citation
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.
Results Reference
result
PubMed Identifier
22675711
Citation
Chira 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.
Results Reference
result
PubMed Identifier
16432674
Citation
Balik 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.
Results Reference
result
PubMed Identifier
17079257
Citation
Diacon 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.
Results Reference
result
PubMed Identifier
29245326
Citation
Chira RI, Chira A, Mircea PA, Valean S. Mediastinal masses-transthoracic ultrasonography aspects. Medicine (Baltimore). 2017 Dec;96(49):e9082. doi: 10.1097/MD.0000000000009082.
Results Reference
result
PubMed Identifier
29163656
Citation
Hafez 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.
Results Reference
result
PubMed Identifier
16138366
Citation
Schubert 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.
Results Reference
result
PubMed Identifier
1609716
Citation
Yang 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.
Results Reference
result

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Role of Ultrasound Guided Peripheral Thoracic Tumors

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