UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018710 |
|---|---|
| Receipt number | R000021649 |
| Scientific Title | Feasibility of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2016/09/12 14:30:52 |
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Basic information
Public title
Feasibility of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors
Acronym
Feasibility of UEMR for nonampullary duodenal tumors
Scientific Title
Feasibility of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors
Scientific Title:Acronym
Feasibility of UEMR for nonampullary duodenal tumors
Region
| Japan |
Condition
Condition
duodenal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility and safety of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pathological complete resection rate
(completeness of resection on follow-up
endoscopy)
Key secondary outcomes
Endoscopic complete resection rate, R0 resection rate, Procedure time, Total procedure time, Total amount of infusion water, Adverse events
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
1:Nonampullary duodenal tumors that can be removed endoscopically
2:Adenoma or Intramucosal cancer
Key exclusion criteria
1:ampullary tumor
2:tumors that are difficult to remove endoscopically
3:invasive cancer
4:residual lesions after EMR
5:patients with FAP or Lynch syndrome
6:patients with hematological abnormality
7:patients with severe organ failure
8:patients who have been judged as in appropriate for this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriya Uedo |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
uedou-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yamasaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
Homepage URL
yasshifive@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2015 | Year | 08 | Month | 18 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 12 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
A follow up EGD 3 month after duodenal UEMR should be performed.
Management information
Registered date
| 2015 | Year | 08 | Month | 18 | Day |
Last modified on
| 2016 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021649
