UMIN-CTR Clinical Trial

Basic information
Public title	The prospective randomized control study to evaluating partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor
Acronym	PI-UEMR study
Scientific Title	The prospective randomized control study to evaluating partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor
Scientific Title:Acronym	PI-UEMR study
Region	Japan

Condition
Condition	Superficial non-ampullary duodenal epithelial tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of PI-UEMR by comparing to them of UEMR
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	En bloc resection rate with pathologically confirmed negative margins without conversion to ESD (R0 resection rate)
Key secondary outcomes	Amount of submucosal injection agents, procedure time, en bloc resection rate, macroscopic and pathological margin, intra- and post operation complication, conversion rate to ESD

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Partial injection underwater endoscopic mucosal resection (PI-UEMR) Sodium hyaluronate is used for submucosal injection agent.
Interventions/Control_2	Underwater endoscopic mucosal resection (UEMR)
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 over 20 years of age scheduled for endoscopic treatment of lesions diagnosed as non-ampullary duodenal adenoma of 13-20 mm 2) Tumors without stalk 3) Patients who agreed to participate in the study
Key exclusion criteria	1) Cases in which snaring is considered difficult due to poor maneuverability 2) Cases in which suspected submucosal invasive cancer 3) Cases of chronic kidney disease needs dialysis 4) Cases of uncompensated liver cirrhosis 5) Cases of hematologic disease with coagulation dysfunction 6) Cases where antithrombotic management is not possible according to the guidelines of the Japan Gastroenterological Endoscopy Society (Case of a low dose aspirin is enable to treatment without drug withdrawal. 7) Cases of other critical organ failure 8) Cases of multiple duodenal tumors associated with hereditary bowel diseases (i. e; familial colorectal polyposis) 9) Other casess deemed ineligible at a preoperative conference
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Motohiko Middle name Last name Kato
Organization	Keio University School of Medicine
Division name	Gastroenterology and hepatology
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	motohikokato@keio.jp

Public contact
Name of contact person	1st name Yusaku Middle name Last name Takatori
Organization	Keio University School of Medicine
Division name	Cancer Center
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	y_takatori@keio.jp

Sponsor
Institute	Keio University
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	Keio University School of Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 30 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	2020 Year 06 Month 29 Day
Date of IRB	2020 Year 09 Month 03 Day
Anticipated trial start date	2020 Year 09 Month 28 Day
Last follow-up date	2022 Year 03 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	2020 Year 09 Month 22 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047616