UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000047917