UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033817 |
|---|---|
| Receipt number | R000038574 |
| Scientific Title | Assessment of usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2026/03/16 20:10:15 |
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Basic information
Public title
Assessment of usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Acronym
Usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Scientific Title
Assessment of usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Scientific Title:Acronym
Usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Region
| Japan |
Condition
Condition
Benign or malignant pulmonary leision
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate volume of biopsy specimens and diagnostic accuracy of pulmonary lesions usingthe endocytoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic yield using ECS
Key secondary outcomes
Time of procedure
Diagnostic yield according to benign or malignant
intra-observer agreement
inter-observer agreement
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient with a peripheral pulmonary lesion 30mm<= in size who need to undergo EBUS-GS
2.Informed consent
Key exclusion criteria
1.Clinical difficulties in this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takae |
| Middle name | |
| Last name | Okuno |
Organization
Shimane University Hospital
Division name
Medical Oncology and Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho Izumo-shi shimane, Japan
TEL
0853-20-2580
takae007@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takae |
| Middle name | |
| Last name | Okuno |
Organization
Shimane University Hospital
Division name
Medical Oncology and Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho Izumo-shi shimane, Japan
TEL
0853-20-2580
Homepage URL
takae007@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Medical Oncology and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho Izumo-shi shimane, Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.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
島根大学医学部附属病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
10.1111/1759-7714.14731. Epub 2022 Nov 22.
Number of participants that the trial has enrolled
40
Results
Thirty-seven cases were enrolled. The diagnostic accuracy achieved by ECS was 91.9% (34/37). The agreement rate between the endocytoscopic evaluation and pathological diagnosis of each specimen (170 specimens) was 65.3% (111/170). The median time required for endocytoscopic evaluation per specimen was 70 s. When we judged a specimen to be malignant a second time on ECS evaluations of five specimens in one case, pathologically malignant specimens were collected in 26 of 27 cases (96.3%).
Results date posted
| 2026 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the 40 cases enrolled, two cases were excluded because fewer than five specimens had been collected, whereas another was excluded because cancer was diagnosed without endocytoscopic evaluation. Specimens from the remaining 37 cases were evaluated.
Of 37 cases, 28 were male and nine were female, with a median age of 72 (57-87) years. Twenty-seven lesions were pathologically diagnosed as malignant based on bronchoscopic biopsy specimens, comprising 17 adenocarcinomas, seven squamous cell carcinomas, and three small cell carcinomas. Ten lesions were not pathologically diagnosed as malignant based on bronchoscopic biopsy specimens.
Participant flow
Forty cases were enrolled, and three inappropriate cases were excluded. Of the 37 cases evaluated, 27 were malignant, and 10 were pathologically non-malignant on bronchoscopic specimens. A total of 185 specimens were obtained from 37 cases. Among them, 170 specimens were evaluated following the exclusion of 15 inappropriate specimens.
Adverse events
None
Outcome measures
The outcome measures were as follows: (a) diagnostic accuracy using ECS; (b) agreement rate between ECS evaluation and pathological diagnosis in each specimen; (c) duration of ECS evaluation; (d) cumulative diagnostic yield of sequential biopsies of lesions pathologically diagnosed as malignant; (e) correlation between collection of malignant tissue and the number of specimens evaluated as malignant based on ECS; and (f) inter-observer and intra-observer agreement.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038574
