UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026184 |
|---|---|
| Receipt number | R000030085 |
| Scientific Title | Standardization of safer doudenal ESD: analysis observation study of typical procedure of duodenal ESD |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2018/10/11 16:51:59 |
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Basic information
Public title
Standardization of safer doudenal ESD: analysis observation study of typical procedure of duodenal ESD
Acronym
Standardization of safer doudenal ESD
Scientific Title
Standardization of safer doudenal ESD: analysis observation study of typical procedure of duodenal ESD
Scientific Title:Acronym
Standardization of safer doudenal ESD
Region
| Japan |
Condition
Condition
Duodenal adenoma or cancer
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of combination ESD using pre-clipping method, ring thread countertraction method and closure of the Over The Scope Clip
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perforation rate during duodenal ESD
Key secondary outcomes
Bleeding rate
Procedure time
Delayed perforation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Ring shaped counter traction
Interventions/Control_2
OTSC
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
| 25 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria
75 patient who are diagnosed with duodenal adenoma or early duodenal cancer (over 20mm in diameter) and performed ESD.
Key exclusion criteria
Exclusion criteria
1.Diagnosed with Diabetes Mellitus
2.Taking Steroid or immune suupress drugs
3.Chr.pancreatitis
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Ehime Rosai Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-27, minami komatubara, niihama, Ehime, Japan
TEL
0897-33-6191
hiro4884@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Ehime Rosai Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-27, minami komatubara, niihama, Ehime, Japan
TEL
0897-33-6191
Homepage URL
hiro4884@med.kagawa-u.ac.jp
Sponsor or person
Institute
Ehime Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime Rosai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Ehime Rosai Hospital
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
82,83
Org. issuing International ID_1
Ehime Rosai Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 17 | 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
| 2017 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
From ethical point of view, investigation are performed
Management information
Registered date
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030085
