UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041265 |
|---|---|
| Receipt number | 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 | 2023/08/29 20:31:30 |
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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
| Gastroenterology |
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 dotted marking, a small amount of saline 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 dotted marking, saline 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 between 5 mm to 20 mm.
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 related 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
208
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
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
khashiguchi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
22
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
Terminated
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | 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
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047124
