UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030414 |
|---|---|
| Receipt number | R000034729 |
| Scientific Title | Efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm): a multicenter observational study |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2021/12/18 15:44:38 |
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Basic information
Public title
Efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm): a multicenter observational study
Acronym
D-UEMR Study
Scientific Title
Efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm): a multicenter observational study
Scientific Title:Acronym
D-UEMR Study
Region
| Japan |
Condition
Condition
duodenal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Complete resection rate(Recurrence rate 12 month after UEMR)
Key secondary outcomes
Resected lesion and specimen size
En bloc resection rate
R0 resection rate
Procedure time
Total procedure time
Total amount of infusion water
Adverse events rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nonampullary duodenal tumors less than 20mm in size endoscopically (adenoma or intramucosal cancer)
Apart from papillae
Within 2 lesions in 1 patient
Key exclusion criteria
Suspect of submucosal invasive cancer
Patients with FAP or Lynch syndrome
Patients with less than 1 year prognosis
Patients who have been judged as in appropriate for this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Okada |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Yamasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7219
Homepage URL
yasshifive@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
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
Okayama University Hospital
Address
2-5-1 Shikata-cyo Okayama
Tel
+81-86-235-7219
yasshifive@yahoo.co.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
岩国医療センター（山口県）
大阪国際がんセンター（大阪府）
岡山医療センター（岡山県）
岡山大学病院（岡山県）
岡山済生会総合病院（岡山県）
北野病院（大阪府）
京都第二赤十字病院（京都府）
京都府立医科大学附属病院（京都府）
津山中央病院（岡山県）
奈良県西和医療センター（奈良県）
日本赤十字社 和歌山医療センター（和歌山県）
姫路赤十字病院（兵庫県）
広島市民病院（広島県）
福山医療センター（広島県）
三豊総合病院（香川県）
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
155
Results
Primary endpoint
non-recurrence rate 97.2%(95%CI 92.8-99.1)
Results date posted
| 2021 | Year | 12 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
20mm duodenal adenomas
Participant flow
Enrollment before UEMR
follow up EGD with biopsies until 12 months after UEMR
Adverse events
Perforation 0%
Delayed bleeding 1.2%
Outcome measures
Non recurrence rate 97.2%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the efficacy of UEMR for SNADETS
Evaluate the recurrence 2 month and 12 month after UEMR
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034729
