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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Esophageal varices requiring endoscopic therapies | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |