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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041265
Receipt No. R000047124
Scientific Title Randomized controlled trial on the feasibility and safety of "Underwater endoscopic mucosal resection with injection" versus "conventional endoscopic mucosal resection" for superficial nonampullary duodenal epithelial tumors
Date of disclosure of the study information 2020/08/01
Last modified on 2020/08/05

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Basic information
Public title Randomized controlled trial on the feasibility and safety of "Underwater endoscopic mucosal resection with injection" versus "conventional endoscopic mucosal resection" for superficial nonampullary duodenal epithelial tumors
Acronym UEMRI vs CEMR study
Scientific Title Randomized controlled trial on the feasibility and safety of "Underwater endoscopic mucosal resection with injection" versus "conventional endoscopic mucosal resection" for superficial nonampullary duodenal epithelial tumors
Scientific Title:Acronym UEMRI vs CEMR study
Region
Japan

Condition
Condition Superficial nonampullary duodenal epithelial tumor
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To conduct a comparative study on the feasibility and safety of "Underwater endoscopic mucosal resection with injection (UEMRI)" and "conventional endoscopic mucosal resection (CEMR)" for superficial nonampullary duodenal epithelial tumors of 20 mm or less.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes En bloc resection rate
Remnant/recurrence rate at 6 months later after procedure
Procedure time
Total procedure time
Adverse events rate

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 Underwater EMR with injection (UEMRI) group; after marking, a small amount of saline or sodium hyaluronate is injected to submucosal layer. The lumen is deflated and filled with saline. The floating lesion is grasped and resected with a electrosurgical snare. After confirming that there are no bleeding, perforation and residual lesions, complete closure is performed by endoclips.
Interventions/Control_2 Conventional EMR group; after marking, a 10% glycerin solution is injected submucosal layer. The lesion is grasped and resected with a electrosurgical snare. After confirming that there are no bleeding, perforation and residual lesions, complete closure is performed by endoclips.
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) Superficial nonampullary duodenal epithelial tumors with a size of 20mm or less
2) Adenoma or intramucosal cancer
Key exclusion criteria 1) Lesions near the papillae
2) Suspect of submucosal invasive cancer
3) Residual lesions after endoscopic resection
4) Patients with FAP or Lynch syndrome
5) Patients with hematological abnormality
6) Patients with severe organ failure
7) Patients who have been judged as inappropriate for this study
Target sample size 68

Research contact person
Name of lead principal investigator
1st name Keiichi
Middle name
Last name Hashiguchi
Organization Nagasaki University Hospital
Division name Department of Endoscopy
Zip code 852-8501
Address 1-7-1, Sakamoto, Nagasaki 852-8501, Japan.
TEL 095-819-7489
Email khashiguchi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Keiichi
Middle name
Last name Hashiguchi
Organization Nagasaki Unicersity Hospital
Division name Department of Endoscopy
Zip code 852-8501
Address 1-7-1, Sakamoto, Nagasaki 852-8501, Japan.
TEL 095-819-7489
Homepage URL
Email khashiguchi@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki 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 Nagasaki University Hospital
Address 1-7-1, Sakamoto, Nagasaki 852-8501, Japan.
Tel 095-819-7726
Email rinshou7726@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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 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 07 Month 30 Day
Last modified on
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047124

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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