Cargando…

The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol

BACKGROUND: Ossification of the ligamentum flavum (OLF) is the most common cause of thoracic spinal stenosis, which responds poorly to conservative treatment. Thus, surgery is the only effective treatment for OLF. The existence of dural ossification (DO) makes surgery challenging and increases the r...

Descripción completa

Detalles Bibliográficos
Autores principales: Chen, Guanghui, Zhang, Baoliang, Tao, Liyuan, Chen, Zhongqiang, Sun, Chuiguo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AME Publishing Company 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791266/
https://www.ncbi.nlm.nih.gov/pubmed/33437805
http://dx.doi.org/10.21037/atm-20-5439
_version_ 1783633575448412160
author Chen, Guanghui
Zhang, Baoliang
Tao, Liyuan
Chen, Zhongqiang
Sun, Chuiguo
author_facet Chen, Guanghui
Zhang, Baoliang
Tao, Liyuan
Chen, Zhongqiang
Sun, Chuiguo
author_sort Chen, Guanghui
collection PubMed
description BACKGROUND: Ossification of the ligamentum flavum (OLF) is the most common cause of thoracic spinal stenosis, which responds poorly to conservative treatment. Thus, surgery is the only effective treatment for OLF. The existence of dural ossification (DO) makes surgery challenging and increases the risk of intra-/post-operative complications. To date, several methods have been proposed to identify DO, but either the diagnostic accuracy is low or the feasibility is poor. Therefore, the aim of this study was to propose a new imaging sign (Banner cloud sign, BCs), evaluate the accuracy of BCs in the diagnosis of DO, and provide reliable evidence-based data for its application in clinical practice. METHODS: A prospective, blinded, diagnostic accuracy study will be conducted to assess and compare the accuracy of BCs in the diagnosis of DO with other radiological signs [Tram track sign (TTs) and Comma sign (Cs)]. A total of 120 patients diagnosed with OLF who underwent decompression at the Peking University Third Hospital between January 2018 and June 2019 will be enrolled. Patients’ medical records and imaging data will be retrieved from the hospital database server. An observational group consisting of six spine surgeons (with different seniority levels) and two epidemiological researchers will read the patients’ images to identify typical imaging signs and determine the presence of DO. Surgical records will be reviewed to confirm the presence of DO, and the results will serve as the reference standard for estimating accuracy. The primary outcome of the study is to determine the accuracy of BCs for DO diagnosis, and the secondary outcome is to compare the sensitivity, specificity, area under the receiver operating characteristic (ROC) curve and inter-observer reliability of each imaging sign. The time taken and level of confidence in DO diagnosis of each observer will also be compared. DISCUSSION: This study represents the first large-scale investigation of the diagnostic value of BCs, TTs and Cs in the diagnosis of DO, and will provide convincing evidence about their clinical application. TRIAL REGISTRATION: Registered on 29 February 2020. Trial number is ChiCTR2000030380.
format Online
Article
Text
id pubmed-7791266
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher AME Publishing Company
record_format MEDLINE/PubMed
spelling pubmed-77912662021-01-11 The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol Chen, Guanghui Zhang, Baoliang Tao, Liyuan Chen, Zhongqiang Sun, Chuiguo Ann Transl Med Study Protocol BACKGROUND: Ossification of the ligamentum flavum (OLF) is the most common cause of thoracic spinal stenosis, which responds poorly to conservative treatment. Thus, surgery is the only effective treatment for OLF. The existence of dural ossification (DO) makes surgery challenging and increases the risk of intra-/post-operative complications. To date, several methods have been proposed to identify DO, but either the diagnostic accuracy is low or the feasibility is poor. Therefore, the aim of this study was to propose a new imaging sign (Banner cloud sign, BCs), evaluate the accuracy of BCs in the diagnosis of DO, and provide reliable evidence-based data for its application in clinical practice. METHODS: A prospective, blinded, diagnostic accuracy study will be conducted to assess and compare the accuracy of BCs in the diagnosis of DO with other radiological signs [Tram track sign (TTs) and Comma sign (Cs)]. A total of 120 patients diagnosed with OLF who underwent decompression at the Peking University Third Hospital between January 2018 and June 2019 will be enrolled. Patients’ medical records and imaging data will be retrieved from the hospital database server. An observational group consisting of six spine surgeons (with different seniority levels) and two epidemiological researchers will read the patients’ images to identify typical imaging signs and determine the presence of DO. Surgical records will be reviewed to confirm the presence of DO, and the results will serve as the reference standard for estimating accuracy. The primary outcome of the study is to determine the accuracy of BCs for DO diagnosis, and the secondary outcome is to compare the sensitivity, specificity, area under the receiver operating characteristic (ROC) curve and inter-observer reliability of each imaging sign. The time taken and level of confidence in DO diagnosis of each observer will also be compared. DISCUSSION: This study represents the first large-scale investigation of the diagnostic value of BCs, TTs and Cs in the diagnosis of DO, and will provide convincing evidence about their clinical application. TRIAL REGISTRATION: Registered on 29 February 2020. Trial number is ChiCTR2000030380. AME Publishing Company 2020-12 /pmc/articles/PMC7791266/ /pubmed/33437805 http://dx.doi.org/10.21037/atm-20-5439 Text en 2020 Annals of Translational Medicine. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) .
spellingShingle Study Protocol
Chen, Guanghui
Zhang, Baoliang
Tao, Liyuan
Chen, Zhongqiang
Sun, Chuiguo
The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol
title The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol
title_full The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol
title_fullStr The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol
title_full_unstemmed The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol
title_short The diagnostic accuracy of CT-based “Banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol
title_sort diagnostic accuracy of ct-based “banner cloud sign” for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791266/
https://www.ncbi.nlm.nih.gov/pubmed/33437805
http://dx.doi.org/10.21037/atm-20-5439
work_keys_str_mv AT chenguanghui thediagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT zhangbaoliang thediagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT taoliyuan thediagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT chenzhongqiang thediagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT sunchuiguo thediagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT chenguanghui diagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT zhangbaoliang diagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT taoliyuan diagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT chenzhongqiang diagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol
AT sunchuiguo diagnosticaccuracyofctbasedbannercloudsignforduralossificationinpatientswiththoracicossificationoftheligamentumflavumaprospectiveblindeddiagnosticaccuracystudyprotocol