UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion
Acronym	UEMR for nonampullary duodenal adenoma
Scientific Title	Efficacy and safety of underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion
Scientific Title:Acronym	UEMR for nonampullary duodenal adenoma
Region	Japan

Condition
Condition	Nonampullary duodenal adenomatous lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the efficacy and safety of endoscopic underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The rate of pathological local recurrence at 3 months after underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion by biopsy from the scar post UEMR
Key secondary outcomes	The rate of morphological local recurrence at 3 months after underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion, patients' characteristics (e.g. age, gender), lesions' characteristics (e.g. location, diameter, macroscopic appearance), safety (e.g. complications), and relationship between these and outcomes of other endoscopic therapy

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesions
Key exclusion criteria	Patients evaluated incompetent by doctors in attendance
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code	260-8677
Address	Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	043-226-2083
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Maruoka
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	043-226-2083
Homepage URL
Email	maruoka-cib@umin.ac.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
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	Graduate School of Medicine, Chiba University
Address	1-8-1, Inohana, Chuo-Ku, Chiba, Japan
Tel	0432227171
Email	maruoka-cib@umin.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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 06 Day

Related information
URL releasing protocol	https://www.giejournal.org/action/showPdf?pii=S0016-5107%2818%2931949-7
Publication of results	Published

Result
URL related to results and publications	https://www.giejournal.org/action/showPdf?pii=S0016-5107%2818%2931949-7
Number of participants that the trial has enrolled	18
Results	The mean size of the lesions was 13.3+-6.0mm. Low-grade dysplasia, high-grade dysplasia, and intramucosal carcinoma were 4, 10, and 5, respectively. The rates of en bloc and R0 resections were 68.4% and 31.6%, respectively. There were no cases of perforation or delayed bleeding. Additionally, there were no cases of residual tumors by pathological assessment via biopsy 3 months after UEMR.
Results date posted	2022 Year 01 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The mean age of the patients was 62.7+-8.6 years. Eleven were male and 7 were female.
Participant flow	Nineteen SNADETs lesions from 18 patients were resected via UEMR.
Adverse events	None
Outcome measures	The rate of pathological local recurrence at 3 months after underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion by biopsy from the scar post UEMR
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 21 Day
Date of IRB	2016 Year 09 Month 21 Day
Anticipated trial start date	2016 Year 09 Month 21 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients who had undergone underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion underwent periodic endoscopy and biopsied post UEMR scar at 3 months after resection.

Management information
Registered date	2016 Year 10 Month 06 Day
Last modified on	2022 Year 01 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027998