UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060340 |
|---|---|
| Receipt number | R000069028 |
| Scientific Title | A Study on the Current Status of Small Bowel Endoscopy in Patients with Small Bowel Tumors |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/13 17:17:31 |
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Basic information
Public title
A Study on the Current Status of Small Bowel Endoscopy in Patients with Small Bowel Tumors
Acronym
A Study on the Current Status of Small Bowel Endoscopy in Patients with Small Bowel Tumors
Scientific Title
A Study on the Current Status of Small Bowel Endoscopy in Patients with Small Bowel Tumors
Scientific Title:Acronym
A Study on the Current Status of Small Bowel Endoscopy in Patients with Small Bowel Tumors
Region
| Japan |
Condition
Condition
Small bowel tmors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the usefulness of single-balloon enteroscopy in patients with small bowel tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concordance rate between the pre-treatment diagnosis (endoscopic diagnosis and/or pathology from biopsy) and the post-treatment diagnosis (surgical pathology or final clinical diagnosis)
Key secondary outcomes
the rate of successful access to the target lesion, the rate of endoscopic biopsy, and the rate of avoidance of diagnostic surgery
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
This retrospective, single-center study reviewed medical records from Showa Medical University Northern Yokohama Hospital. Between September 2005 and July 2024, we included patients who underwent single-balloon enteroscopy for confirmed small bowel tumors.
Key exclusion criteria
Patients with Peutz-Jeghers syndrome and familial adenomatous polyposis were excluded.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | NORIYUKI |
| Middle name | |
| Last name | OGATA |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa Japan
TEL
0459497000
n.ogata@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | NORIYUKI |
| Middle name | |
| Last name | OGATA |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa Japan
TEL
0459497000
Homepage URL
n.ogata@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University
Institute
Department
Personal name
Funding Source
Organization
no
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
Showa Medical University Northern Yokohama Hospital
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa Japan
Tel
0459497000
n.ogata@med.showa-u.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
| 2026 | Year | 01 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective, single-center study reviewed medical records from Showa Medical University Northern Yokohama Hospital. Between September 2005 and July 2024, we included patients who underwent single-balloon enteroscopy for confirmed small bowel tumors.
Management information
Registered date
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069028
