UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045220 |
|---|---|
| Receipt number | R000051658 |
| Scientific Title | EfficAcy and SafetY of Cold Forceps Biopsy for diminutive pharyngeal neoplasms: a randomized controlled trial |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2021/08/23 18:03:45 |
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Basic information
Public title
EfficAcy and SafetY of Cold Forceps Biopsy for diminutive pharyngeal neoplasms: a randomized controlled trial
Acronym
EASY-CFB trial
Scientific Title
EfficAcy and SafetY of Cold Forceps Biopsy for diminutive pharyngeal neoplasms: a randomized controlled trial
Scientific Title:Acronym
EASY-CFB trial
Region
| Japan |
Condition
Condition
Pharyngeal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy and safety of Cold forceps biopsy for diminutive (less than 3mm) pharyngeal neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Endoscopic recurrence rate 3 months after CFB
Key secondary outcomes
Pathological recurrence rate 3 months after CFB, Endoscopic and pathological recurrence rate 12 months after CFB, immediate and delayed bleeding rate, any other adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Jumbo biopsy forceps
Interventions/Control_2
Standard biopsy forceps
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
Patients with diminutive (less than 3mm) pharyngeal neoplasm diagnosed by endoscopic images
Key exclusion criteria
1. Patients with coagulopathy or hemorrhagic disease
2. Pregnancy, breast feeding
3. Patients taking multiple antithrombotic agents
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Shimodate |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
+81864220210
ys13544@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Shimodate |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
+81864220210
Homepage URL
ys13544@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Clinical Research Institute
Address
1-1-1, Miwa, Kurashiki, Okayama
Tel
+81864220210
kenkyu@kchnet.or.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
| 2021 | Year | 08 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
