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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041983
Receipt No. R000047917
Scientific Title Preoperative lung ultrasound evaluation for detecting pleural adhesions: Systematic review and meta-analysis
Date of disclosure of the study information 2020/10/05
Last modified on 2021/01/12

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Basic information
Public title Preoperative lung ultrasound evaluation for detecting pleural adhesions: Systematic review and meta-analysis
Acronym Preoperative lung ultrasound evaluation for detecting pleural adhesions: Systematic review and meta-analysis
Scientific Title Preoperative lung ultrasound evaluation for detecting pleural adhesions: Systematic review and meta-analysis
Scientific Title:Acronym Preoperative lung ultrasound evaluation for detecting pleural adhesions: Systematic review and meta-analysis
Region
Japan

Condition
Condition Pleural adhesions
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating diagnostic accuracy of lung ultrasound for detecting pleural adhesions before thoracic surgery.
Basic objectives2 Others
Basic objectives -Others Diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity and specificity
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Prospective, retrospective or case-control studies assessing sensitivity and specificity of lung sliding sign including sliding sign, gliding sign, absence of seashore sign, barcode sign and stratosphere sign before elective thoracic surgery (thoracotomy or thoracoscopy) will be included.
Key exclusion criteria We will exclude studies about emergent or urgent thoracic surgery, or cardiac surgery. In addition, we will exclude articles based on wrong publication type (review articles, case reports, and animal studies).
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Shiroshita
Organization Ichinomiyanishi Hospital
Division name Department of respiratory medicine
Zip code 494-0001
Address Ichinomiyanishi Hospital, 1 Kaimeihira, Ichinomiya, Aichi, Japan
TEL 080-3807-4960
Email akihirokun8@gmail.com

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Shiroshita
Organization Ichinomiyanishi Hospital
Division name Department of respiratory medicine
Zip code 494-0001
Address Ichinomiyanishi Hospital, 1 Kaimeihira, Ichinomiya, Aichi, Japan
TEL 080-3807-4960
Homepage URL
Email akihirokun8@gmai.com

Sponsor
Institute Ichinomiyanishi Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ichinomiyanishi Hospital
Address Ichinomiyanishi Hospital, 1 Kaimeihira, Ichinomiya, Aichi, Japan
Tel 08038074960
Email akihirokun8@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 10 Month 02 Day
Date of IRB
2020 Year 10 Month 05 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2021 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Database: MEDLINE via Ovid, Embase via Embase.com, the Cochrane Library, the International Clinical Trials Registry Platform without any language or publication period restriction
Index test: Lung ultrasound using convex or linear probe with B mode or M mode. As for B-mode, lung sliding sign or gliding sign will be included. As for M-mode, absence of seashore sign, or presence of barcode sign or stratosphere sign will be included. If only lower cage was assessed, we will use the diagnostic accuracy of ultrasound on lower cage because we usually insert trocar in 5th or 6th intercostal line.
Reference standard: Confirmation of pleural adhesions by other modalities such as dynamic CT scan, macroscopic findings during medical thoracoscopy, and information during operation
Statistical analysis: Bivariate random effects model to calculate overall sensitivity and specificity of the lung sliding sign. We will describe HSROC curve of lung sliding sign with different cut-off points. We plan to perform sub-group analysis of calculating overall sensitivity and specificity with HSROC curve among patients with BMI >= 30 and COPD. As a sensitivity analysis, we will calculate overall sensitivity and specificity by random effects model among articles which did not perform M-mode imaging, and patients with BMI >= 30, and those with COPD.
Akihiro Shiroshita and Kiyoshi Nakashima will screen the title and abstracts of potential included articles. Akihiro Shiroshita and Masafumi Takeshita will extract data from the included articles and evaluate risk of bias and applicability with the modified QUADAS-2 tools. The overall quality evidence will be assessed using GRADE approach.

Management information
Registered date
2020 Year 10 Month 02 Day
Last modified on
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047917

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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