UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041983 |
|---|---|
| Receipt number | 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 10:16:36 |
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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
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
akihirokun8@gmai.com
Sponsor or person
Institute
Ichinomiyanishi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047917
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
