UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016154 |
|---|---|
| Receipt number | R000017781 |
| Scientific Title | Beneficial Effects of Combining Computed Tomography Enteroclysis/Enterography with Capsule Endoscopy for Screening Tumor Lesions in the Small Intestine |
| Date of disclosure of the study information | 2015/01/07 |
| Last modified on | 2015/01/07 22:31:41 |
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Basic information
Public title
Beneficial Effects of Combining Computed Tomography Enteroclysis/Enterography with Capsule Endoscopy for Screening Tumor Lesions in the Small Intestine
Acronym
Beneficial Effects of Combining CTE with CE for Screening Tumor Lesions in the Small Intestine
Scientific Title
Beneficial Effects of Combining Computed Tomography Enteroclysis/Enterography with Capsule Endoscopy for Screening Tumor Lesions in the Small Intestine
Scientific Title:Acronym
Beneficial Effects of Combining CTE with CE for Screening Tumor Lesions in the Small Intestine
Region
| Japan |
Condition
Condition
Tumor lesions in the small intestine
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of using computed tomography enteroclysis/enterography (CTE), capsule endoscopy (CE), and CTE with CE for diagnosing tumor lesions in the small intestine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Diagnostic yield of small bowel tumors at the time of capsule endoscopy and CT enteroclysis / enterography, and it was a combination of both.
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
| 21 | years-old | <= |
Age-upper limit
| 87 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)It does not matter age, gender.
2)It does not matter hospitalization, outpatient.
3) After underwent CT enteroclysis / enterography and capsule endoscopy, was elected a case that could follow-up for more than 3 months.
Key exclusion criteria
After underwent capsule endoscopy and CT enteroclysis / enterography, cases that could not be observation for more than 3 months.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
+81-836-22-2241
has-333@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
+81-836-22-2241
Homepage URL
has-333@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
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
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
山口大学医学部附属病院(山口県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A definitive diagnosis of the tumor lesions in the small intestine was determined on the basis of findings from histopathological tests conducted on resected or biopsy specimens collected from Baloon endscopy or surgery.
For patients who did not undergo Baloon endscopy or surgery, the final diagnosis was determined on the basis of clinical and imaging findings.
The criteria for a negative tumor lesions in the small intestines were as follows: 1) no tumor was detected by CE or CTE; 2) the presence of the tumor lesions was negative in Baloon endscopy and surgical findings; and 3) the symptoms believed to be due to neoplastic lesions were absent for more than 3 months after the tests.
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2015 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017781
