UMIN-CTR Clinical Trial

Basic information
Public title	A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Acronym	A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Scientific Title	A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Scientific Title:Acronym	A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Region	Japan

Condition
Condition	superficial duodenal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of under-gel EMR (UGEMR) for superficial duodenal tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of R0 resection
Key secondary outcomes	The rate of bleeding The rate of perforation The rate of en bloc resection The rate of recurrence procedure time The usage amount of gel

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients with superficial duodenal tumors indicated for EMR.
Key exclusion criteria	1) Patients whose lesions extent to papilla of Vater. 2) Patients whose lesions are 20 mm or more. 3) Patients whose lesions are endoscopically suspected of submucosal invasion. 4) Patients with residual or recurrent lesions after endoscopic resection. 5) Patients with familial adenomatous polyposis or Lynch syndrome. 6) Patients with bleeding tendency. 7) Patients who are judged by attending doctors as not suitable for this trial.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Nakaoka Middle name Last name Michiko
Organization	Omori Red Cross Hospital
Division name	Gastroenterology
Zip code	143-8527
Address	4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
TEL	+81-3-3775-3111
Email	michiko_cinnamon@ybb.ne.jp

Public contact
Name of contact person	1st name Nakaoka Middle name Last name Michiko
Organization	Omori Red Cross Hospital
Division name	Gastroenterology
Zip code	143-8527
Address	4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
TEL	+81-3-3775-3111
Homepage URL
Email	michiko_cinnamon@ybb.ne.jp

Sponsor
Institute	Omori Red Cross Hospital, Department of Gastroenterology
Institute
Department

Funding Source
Organization	This study do not need financial support
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiratsuka City Hospital, Chigasaki Municipal Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Omori Red Cross Hospital
Address	4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
Tel	+81-3-3775-3111
Email	michiko_cinnamon@ybb.ne.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	大森赤十字病院(東京都)

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 07 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 06 Month 01 Day
Date of IRB	2021 Year 09 Month 02 Day
Anticipated trial start date	2021 Year 09 Month 02 Day
Last follow-up date	2023 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To assess the safety and efficacy of under-gel EMR (UGEMR) for superficial duodenal tumor

Management information
Registered date	2021 Year 09 Month 07 Day
Last modified on	2022 Year 10 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051554