UMIN-CTR Clinical Trial

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

Contact us.