UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039054 |
|---|---|
| Receipt number | R000044538 |
| Scientific Title | Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions |
| Date of disclosure of the study information | 2020/01/05 |
| Last modified on | 2020/01/05 13:46:50 |
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Basic information
Public title
Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Acronym
Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Scientific Title
Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Scientific Title:Acronym
Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Region
| Japan |
Condition
Condition
To assess the potential of the ultrasonographic sliding lung sign to detect severe intrathoracic adhesions before surgery.
Classification by specialty
| Surgery in general | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the potential of the ultrasonographic sliding lung sign to detect severe intrathoracic adhesions before surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the potential of the ultrasonographic sliding lung sign to detect severe intrathoracic adhesions before surgery.
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
all patients aged 20 to 89 years who were admitted for elective thoracic surgery
Key exclusion criteria
pneumothorax, hydrothorax, hemothorax, pyothorax, chylothorax, median sternotomy, psychiatric disorders that inhibited participation, and inappropriate participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
Joetsu General Hospital
Division name
Division of Thoracic Surgery
Zip code
9438507
Address
616 Daido-Fukuda, Joetsu, Niigata
TEL
025-524-3000
hommat@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
Joetstu General Hospital
Division name
Division of Thoracic Surgery
Zip code
9438507
Address
616 Daido-Fukuda, Joetsu, Niigata
TEL
025-524-3000
Homepage URL
hommat@med.u-toyama.ac.jp
Sponsor or person
Institute
Joestu General 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
Joetsu General Hospital
Address
616 Daido-Fukuda, Joetsu, Niigata
Tel
025-524-3000
hommat@med.u-toyama.a.jp
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 | 01 | Month | 05 | Day |
Related information
URL releasing protocol
https://joetsu-hp.jp
Publication of results
Partially published
Result
URL related to results and publications
https://joetsu-hp.jp
Number of participants that the trial has enrolled
168
Results
All 15 patients without the sliding lung sign had hard severe adhesions [specificity 100%, sensitivity 88.2%, positive predictive value 100%, negative predictive value 98.7%, and area under curve 0.94]. There were two false-negative results, both of which were soft adhesions. Thoracotomy frequency, intraoperative bleeding, operative time, and postoperative hospitalization were significantly greater in these patients than in those with non-severe adhesions.
Results date posted
| 2020 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 269 patients were assessed for eligibility, 101 of whom were excluded after the application of exclusion criteria. A total of 168 patients consented to participate and were enrolled. No patient withdrew from the study
Participant flow
In total, 269 patients were assessed for eligibility, 101 of whom were excluded after the application of exclusion criteria. A total of 168 patients consented to participate and were enrolled. No patient withdrew from the study
Adverse events
nothing
Outcome measures
The ultrasound sliding lung sign could be used to predict severe intrathoracic adhesions before surgery. Preoperative confirmation of the ultrasound sliding lung sign is important for planning surgical approaches and implementing appropriate safety management.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 01 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044538
| Research Plan | |
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| Registered date | File name |
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