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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000027375 |
Receipt No. | R000031367 |
Scientific Title | Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study) |
Date of disclosure of the study information | 2018/01/22 |
Last modified on | 2019/10/25 |
Basic information | ||
Public title | Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study) | |
Acronym | Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration | |
Scientific Title | Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study) | |
Scientific Title:Acronym | Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration | |
Region |
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Condition | ||
Condition | Lung cancer, Sarcoidosis | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine the appropriate number of needle stroke movements per puncture in EBUS-TBNA. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The detectability of lesions in three groups according to the number of the stroke movements: the low-number group (20 times), the moderate-number group (25 times), and the high-number group (30 times). |
Key secondary outcomes | 1)Correlation between the detectability and size of lesions
2)The detectability of lesions of lung cancer and sarcoidosis. 3)The detectability of non-necrotizing granulomas in TBLB and EBUS-TBNA. 4)The rate of contraflow of blood in the EBUS-TBNA procedures |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | all patients with histologically proven lung cancer or sarcoidosis who had previously undergone EBUS-TBNA at the University of Miyazaki Hospital between April 2014 and July 2016. | |||
Key exclusion criteria | the patients rejected to use the data for the clinical study | |||
Target sample size | 128 |
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Name of lead principal investigator |
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Organization | Faculty of Medicine, University of Miyazaki | ||||||
Division name | Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | Kihara 5200, Kiyotake, Miyazaki | ||||||
TEL | 0985-85-2965 | ||||||
hironobu_tsubouchi@med.miyazaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Faculty of Medicine, University of Miyazaki | ||||||
Division name | Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | Kihara 5200, Kiyotake, Miyazaki | ||||||
TEL | 0985-85-2965 | ||||||
Homepage URL | |||||||
hironobu_tsubouchi@med.miyazaki-u.ac.jp |
Sponsor | |
Institute | University of Miyazaki |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
Institutions | |
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Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |||||||
URL related to results and publications | |||||||
Number of participants that the trial has enrolled | 128 | ||||||
Results | We reviewed the EBUS-TBNA data of sarcoidosis (n = 29) and lung cancer (n = 99) patients. Using the data of their 43 sarcoidosis and 139 lung cancer lymph nodes, we evaluated the correlation between the detectability of granulomatous lesions or malignant lesions and the number of needle-stroke movements.
The number of needle stroke may influence the detectability of granulomatous lesions in sarcoidosis due to blood contamination caused by the contraflow of blood. |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | Study Design: Cross-sectional study.
Setting & Participants: Among subjects who had undergone EBUS-TBNA between April 2014 and July 2016. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031367 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
Registered date | File name |