UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028433 |
|---|---|
| Receipt number | R000032545 |
| Scientific Title | Efficacy of capsule endoscopy in cirrhotic patients for the diagnosis of upper gastrointestinal lesions and small bowel abnormalities |
| Date of disclosure of the study information | 2017/07/28 |
| Last modified on | 2017/07/28 20:17:39 |
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Basic information
Public title
Efficacy of capsule endoscopy in cirrhotic patients for the diagnosis of upper gastrointestinal lesions and small bowel abnormalities
Acronym
Capsule endoscopy and gastrointestinal lesions
Scientific Title
Efficacy of capsule endoscopy in cirrhotic patients for the diagnosis of upper gastrointestinal lesions and small bowel abnormalities
Scientific Title:Acronym
Capsule endoscopy and gastrointestinal lesions
Region
| Japan |
Condition
Condition
Esophageal varices requiring endoscopic therapies
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of the current prospective interventional study are to investigate the diagnostic usefulness of capsule endoscopy for gastrointestinal lesions in liver cirrhosis patients with esophageal varices receiving endoscopic therapies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence for small bowel lesions (small bowel lesions will be defined as follows: (a) vascular lesion or (b) ulcerative lesion). Tumor lesion will not be included for small bowel lesions in this study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Capsule endoscopy for patiens with esophageal varices receiving endoscopic therapy
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 with portal hypertension who were determined to be necessary for prophylactic endoscopic therapies for esophageal varices
Key exclusion criteria
(1)Patients aged less than 18 years
(2)Patients with gastrointestinal obstruction or fistula or those being suspected of having gastrointestinal obstruction or fistula
(3)Patients with gastrointestinal stenosis in whom capsule endoscopy will be remained in the same place.
(4)Patients with cardiac pacemakers or other implanted medical devices
(5)Patients with dysphagia
(6)Patients in whom consents for removal of remained CE are unable to be obtained
(7)Patients who are unable to receive open surgery
(8)Patients who were judged to be inappropriate for the study subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei Nishiguchi |
Organization
Hyogo college of medicine
Division name
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL
0798-45-6472
kantan@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Iwata |
Organization
Hyogo college of medicine
Division name
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL
0798-45-6472
Homepage URL
yo-iwata@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo college of medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 28 | 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
| 2017 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 28 | Day |
Last modified on
| 2017 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032545
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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