UMIN-CTR Clinical Trial

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
Email	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
Email	ys13544@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital Gastroenterology and Hepatology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051658