UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and safety of Cold Forceps Polypectomy for the non-ampullary dudenoal adenoma of less than 6mm.
Acronym	The feasibility trial of Cold Forceps Polypectomy for the non-ampullary duodenal adenoma of less than 6mm.
Scientific Title	The efficacy and safety of Cold Forceps Polypectomy for the non-ampullary dudenoal adenoma of less than 6mm.
Scientific Title:Acronym	The feasibility trial of Cold Forceps Polypectomy for the non-ampullary duodenal adenoma of less than 6mm.
Region	Japan

Condition
Condition	non-ampullary duodenal adenoma of less than 6mm
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To exame the feasibility of Cold Forceps Polypectomy for the non-ampullary duodenal adenoma of less than 6mm.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	disappearance rate of adenoma by the Cold Forceps Polypectomy
Key secondary outcomes	1.Adverse event 2Total number of biopsy tissue 3.Total number of procedure 4.Procedure time 5.histlogical assessment

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	repeat the cold forceps biopsy to the lesion
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. endoscopically and histologicaly diagnosed as non-amupullary duodenal adenoma of less than 6mm. 2. without non-ampullary duodenal adenoma over 11mm 3. written informed consent was performed
Key exclusion criteria	1. can not performe biopsy because of the anti-coaglant drugs. 2. bad general status 3. pregnant or lactating 4. The cases who may not alive over one year. 5. physician judge to be inappropriate
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Okada
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code	7008558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
TEL	086-235-7219
Email	hiro@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Hiromitsu Middle name Last name Kanzaki
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
TEL	086-235-7219
Homepage URL
Email	kanzaki@qc4.so-net.ne.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science Department of Gastroenterology and Hepatology
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
Tel	0862357219
Email	mae6605@adm.okayama-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	岡山大学病院（岡山県）、津山中央病院（岡山県）、広島市立市民病院（広島県）、倉敷中央病院（岡山県）、姫路赤十字病院（兵庫県）、福山医療センター（広島県）、岡山市民病院（岡山県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/35859656/
Number of participants that the trial has enrolled	39
Results	Primary outcome: Tumor disappearance after one-year: 38/39 cases (97.4%) Median tumor diameter: 5 (3-6) mm Morphology: superficial elevated / superficial depressed / protruded = 19/13/7 Location: bulb / 2nd (pre-Vater) / 2nd (post-Vater) = 1/18/20
Results date posted	2020 Year 02 Month 02 Day
Results Delayed	Delay expected
Results Delay Reason	Due to delay in paper submission
Date of the first journal publication of results	2022 Year 06 Month 10 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 01 Month 30 Day
Date of IRB	2017 Year 03 Month 21 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 12 Month 30 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 02 Month 28 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	Published on Endoscopy international Open https://pubmed.ncbi.nlm.nih.gov/35859656/

Management information
Registered date	2017 Year 01 Month 30 Day
Last modified on	2022 Year 08 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029794