UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018989 |
|---|---|
| Receipt number | R000021963 |
| Scientific Title | A comparative study to assess the safety and efficacy of underwater EMR for intermediate size (10-20 mm) colorectal polyps. |
| Date of disclosure of the study information | 2015/09/12 |
| Last modified on | 2019/05/07 22:46:33 |
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Basic information
Public title
A comparative study to assess the safety and efficacy of underwater EMR for intermediate size (10-20 mm) colorectal polyps.
Acronym
UEMR vs C-EMR study
Scientific Title
A comparative study to assess the safety and efficacy of underwater EMR for intermediate size (10-20 mm) colorectal polyps.
Scientific Title:Acronym
UEMR vs C-EMR study
Region
| Japan |
Condition
Condition
Sessile colorectal polys 10mm - 20mm in diameter.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of UEMR for 10-20 mm sessile colorectal polyp in comparison with those of conventional EMR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Histologic complete resection rate
Key secondary outcomes
Endoscopic complete resection rate, R0 resection rate, Adverse events, Total procedure time, The incidende of residual poyp on follow-up colonoscopy 12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Underwater EMR group
Interventions/Control_2
Conventional EMR group
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)Patients undergoing colorectal polypectomy (polyps < 10mm)
2) Written Informed consent.
3) 20 y.o. <
Key exclusion criteria
1)pedunculated polyp
2)residual lesions after EMR
3)patients with marked electrolyte abnormality
4)patients with hematological abnormality
5)patients with severe organ failure
6) patients with inflammatory bowel disease and polyposis
7) patients who have been judged as inappropriate for this study
Target sample size
230
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
3-1-69, Ohtemae, Chuo-ku, Osaka 541-8567, Japan.
TEL
06-6945-1181
uedou-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwatsubo taro |
Organization
Osaka international cancer institute
Division name
Department of Gastrointestinal Oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka, Japan
TEL
06-6945-1181
Homepage URL
iwatubo-ta@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka international cancer institute
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
Japanese Red Cross Osaka Hospital
Japanese Red Cross Society Wakayama Medical Center
Kyoto Second Red Cross Hospital
Kyoto Katsura Hospital
Wakayama Medical University
Osaka National Hospital
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
大阪国際がんセンター(大阪府)、大阪赤十字病院(大阪府)、日本赤十字社和歌山医療センター(和歌山県)、京都第二赤十字病院(京都府)、京都桂病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 12 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021963
