UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060637 |
|---|---|
| Receipt number | R000069354 |
| Scientific Title | An observational study to evaluate the efficacy and safety of endoscopic treatment for non-ampullary duodenal tumors |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/10 10:26:13 |
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Basic information
Public title
An observational study to evaluate the efficacy and safety of endoscopic treatment for non-ampullary duodenal tumors
Acronym
Duodenal Non-ampullary Epithelial Tumor / Endoscopic Study
Scientific Title
An observational study to evaluate the efficacy and safety of endoscopic treatment for non-ampullary duodenal tumors
Scientific Title:Acronym
Duodenal Non-ampullary Epithelial Tumor / Endoscopic Study
Region
| Japan |
Condition
Condition
Patients who underwent endoscopic treatment for duodenal tumors at our institution between April 2011 and March 2027
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
o evaluate the efficacy and safety of endoscopic treatment in patients with duodenal tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic curative resection rate
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with duodenal tumors
Patients who underwent endoscopic resection
Patients aged 18 years or older at the time of endoscopic treatment
No restriction on sex
Key exclusion criteria
Patients who opted out of participation (i.e., requested not to be included in the study).
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
nobomisa@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Misawa |
Organization
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama
Division name
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
09061961466
Homepage URL
nobomisa@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City 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
Yokohama City University Affiliated Research Ethics Committee for Life Sciences and Medical Research Involving Human Subjects
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
0457872800
nobomisa@hotmail.co.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
| 2026 | Year | 02 | Month | 10 | 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
| 2024 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069354
