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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028433
Receipt No. 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

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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
Email 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
Email yo-iwata@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032545

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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