UMIN-CTR Clinical Trial

Basic information
Public title	Investigation for Locoregional Recurrences of Underwater Endoscopic Mucosal Resection for Intermediate-Size Colorectal Polyps
Acronym	Investigation for Locoregional Recurrences of UEMR for Colorectal Polyps
Scientific Title	Investigation for Locoregional Recurrences of Underwater Endoscopic Mucosal Resection for Intermediate-Size Colorectal Polyps
Scientific Title:Acronym	Investigation for Locoregional Recurrences of Underwater Endoscopic Mucosal Resection for Intermediate-Size Colorectal Polyps
Region	Japan

Condition
Condition	Intermediate-size (10-20 mm) sessile colorectal lesions
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of Underwater EMR for posttreatment recurrences of intermediate-size (10-20 mm) sessile colorectal lesions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of locoregional recurrences after one year of endoscopic treatment in all enrolled cases
Key secondary outcomes	Proportion of recurrence-free after endoscopic treatment in all eligible cases Proportion of en bloc resection Proportion of histologically complete resection Proportion of endoscopically complete resection Proportion of adverse events Procedure time

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Conventional EMR Group needle injection of normal saline into the submucosa and snare resection of the lesion
Interventions/Control_2	Underwater EMR(UEMR) Group immersion of the entire lumen in water and snare resection of the lesion without submucosal injection
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.Patients with intermediate-size (10-20 mm) sessile colorectal lesions who can register one lesion on the most proximal side and undergo endoscopic resection. 2.Patients who can be followed from endoscopic resection to follow up colonoscopy. 3.Patients without colorectal neoplastic lesions requiring surgical resection. 4.Patients who are at least 20 years old at enrollment. 5.Patients who have written informed consent from themthelves or a surrogate.
Key exclusion criteria	1.Patients previously enrolled in the study. 2.Lesions suspected of residual recurrence 3.Patients with significant electrolyte (Na, Cl) abnormalities 4.Patients with inflammatory bowel disease and polyposis coli 5.Other patients deemed unsuitable for safe treatment by the investigator
Target sample size	580

Research contact person
Name of lead principal investigator	1st name Noriya Middle name Last name Uedo
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Zip code	541-8567
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	0669451181
Email	uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Yamashina
Organization	Kansai Medical University Medical Center
Division name	3-1-69, Otemae, Chuo-ku, Osaka
Zip code	570-8507
Address	10-15, Fumizono-cho, Moriguchi-City, Osaka
TEL	0669921001
Homepage URL
Email	yamastak@takii.kmu.ac.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Kansai Endoscopic Device Selection Conference
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	Institutional Review Board of the Osaka International Cancer Institute
Address	3-1-69, Otemae, Chuo-ku, Osaka
Tel	0669451181
Email	rinri01@opho.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	2022 Year 10 Month 26 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	2022 Year 10 Month 25 Day
Date of IRB	2022 Year 10 Month 16 Day
Anticipated trial start date	2022 Year 12 Month 01 Day
Last follow-up date	2028 Year 10 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	2022 Year 10 Month 25 Day
Last modified on	2022 Year 12 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056093