UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041860 |
|---|---|
| Receipt number | R000047616 |
| Scientific Title | The prospective randomized control study to evaluating partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2020/10/01 12:13:15 |
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Basic information
Public title
The prospective randomized control study to evaluating partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor
Acronym
PI-UEMR study
Scientific Title
The prospective randomized control study to evaluating partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor
Scientific Title:Acronym
PI-UEMR study
Region
| Japan |
Condition
Condition
Superficial non-ampullary duodenal epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of PI-UEMR by comparing to them of UEMR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En bloc resection rate with pathologically confirmed negative margins without conversion to ESD (R0 resection rate)
Key secondary outcomes
Amount of submucosal injection agents, procedure time, en bloc resection rate, macroscopic and pathological margin, intra- and post operation complication, conversion rate to ESD
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
Partial injection underwater endoscopic mucosal resection (PI-UEMR)
Sodium hyaluronate is used for submucosal injection agent.
Interventions/Control_2
Underwater endoscopic mucosal resection (UEMR)
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 over 20 years of age scheduled for endoscopic treatment of lesions diagnosed as non-ampullary duodenal adenoma of 13-20 mm
2) Tumors without stalk
3) Patients who agreed to participate in the study
Key exclusion criteria
1) Cases in which snaring is considered difficult due to poor maneuverability
2) Cases in which suspected submucosal invasive cancer
3) Cases of chronic kidney disease needs dialysis
4) Cases of uncompensated liver cirrhosis
5) Cases of hematologic disease with coagulation dysfunction
6) Cases where antithrombotic management is not possible according to the guidelines of the Japan Gastroenterological Endoscopy Society
(Case of a low dose aspirin is enable to treatment without drug withdrawal.
7) Cases of other critical organ failure
8) Cases of multiple duodenal tumors associated with hereditary bowel diseases (i. e; familial colorectal polyposis)
9) Other casess deemed ineligible at a preoperative conference
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Gastroenterology and hepatology
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Yusaku |
| Middle name | |
| Last name | Takatori |
Organization
Keio University School of Medicine
Division name
Cancer Center
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
y_takatori@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 09 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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 | 09 | Month | 22 | Day |
Last modified on
| 2020 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047616
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
