UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024309 |
|---|---|
| Receipt number | R000027998 |
| Scientific Title | Efficacy and safety of underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion |
| Date of disclosure of the study information | 2016/10/06 |
| Last modified on | 2022/01/12 19:26:38 |
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Basic information
Public title
Efficacy and safety of underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion
Acronym
UEMR for nonampullary duodenal adenoma
Scientific Title
Efficacy and safety of underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion
Scientific Title:Acronym
UEMR for nonampullary duodenal adenoma
Region
| Japan |
Condition
Condition
Nonampullary duodenal adenomatous lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficacy and safety of endoscopic underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of pathological local recurrence at 3 months after underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion by biopsy from the scar post UEMR
Key secondary outcomes
The rate of morphological local recurrence at 3 months after underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion, patients' characteristics (e.g. age, gender), lesions' characteristics (e.g. location, diameter, macroscopic appearance), safety (e.g. complications), and relationship between these and outcomes of other endoscopic therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesions
Key exclusion criteria
Patients evaluated incompetent by doctors in attendance
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8677
Address
Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Maruoka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuo-Ku, Chiba, Japan
Tel
0432227171
maruoka-cib@umin.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.giejournal.org/action/showPdf?pii=S0016-5107%2818%2931949-7
Publication of results
Published
Result
URL related to results and publications
https://www.giejournal.org/action/showPdf?pii=S0016-5107%2818%2931949-7
Number of participants that the trial has enrolled
18
Results
The mean size of the lesions was 13.3+-6.0mm. Low-grade dysplasia, high-grade dysplasia, and intramucosal carcinoma were 4, 10, and 5, respectively. The rates of en bloc and R0 resections were 68.4% and 31.6%, respectively. There were no cases of perforation or delayed bleeding. Additionally, there were no cases of residual tumors by pathological assessment via biopsy 3 months after UEMR.
Results date posted
| 2022 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the patients was 62.7+-8.6 years.
Eleven were male and 7 were female.
Participant flow
Nineteen SNADETs lesions from 18 patients were resected via UEMR.
Adverse events
None
Outcome measures
The rate of pathological local recurrence at 3 months after underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion by biopsy from the scar post UEMR
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who had undergone underwater endoscopic mucosal resection (UEMR) for nonampullary duodenal adenomatous lesion underwent periodic endoscopy and biopsied post UEMR scar at 3 months after resection.
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027998
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| Registered date | File name |
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