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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000014149 |
Receipt No. | R000016478 |
Scientific Title | A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion |
Date of disclosure of the study information | 2014/06/03 |
Last modified on | 2017/05/31 |
Basic information | ||
Public title | A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion | |
Acronym | EUS-TTNB | |
Scientific Title | A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion | |
Scientific Title:Acronym | EUS-TTNB | |
Region |
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Condition | |||
Condition | Patients who will undergo EUS-FNA for an abdominal solid lesion | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate safety and efficacy of EUS-TTNB |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The diagnostic yield of malignancy (EUS-TTNB, EUS-FNA, EUS-TTNB+EUS-FNA) |
Key secondary outcomes | Technical success, safety, rate of macroscopic tissue sampling, the diagnostic yield of specific diseases |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | EUS-guided through-the-needle biopsy | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients with abdominal solid lesion 15mm amd larger who will undergo EUS-FNA
2)Age 20 years and older 3)ECOG PS 0-3 4)written informed consent |
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Key exclusion criteria | 1)Patients with coagulopathy
2)Patients whose lesions are not safely punctured by EUS-FNA 3)No informed consent 4)Patients who are considered as inappropriate for study enrollment by investigators |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The University of Tokyo, Graduate School of Medicine | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 7-3-1, Hongo, Bunkyo-ku Tokyo | ||||||
TEL | 03-3815-5411 | ||||||
isayama-tky@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | The University of Tokyo, Graduate School of Medicine | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 7-3-1, Hongo, Bunkyo-ku Tokyo | ||||||
TEL | 03-3815-5411 | ||||||
Homepage URL | |||||||
ynakai-tky@umin.ac.jp |
Sponsor | |
Institute | The University of Tokyo |
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 | |
Address | |
Tel | |
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 | 東京大学医学部付属病院(東京都), 岐阜大学附属病院(岐阜県), 岐阜市民病院(岐阜県), 東京警察病院(東京都), 日本赤十字社医療センター(東京都), 関東中央病院(東京都) |
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 | |
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 | Terminated | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000016478 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |