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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000025048 |
Receipt No. | R000028829 |
Scientific Title | Usefulness of Direct Peroral Cholangioscopy Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones |
Date of disclosure of the study information | 2019/11/29 |
Last modified on | 2016/11/29 |
Basic information | ||
Public title | Usefulness of Direct Peroral Cholangioscopy Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones | |
Acronym | Usefulness of Direct POC Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones | |
Scientific Title | Usefulness of Direct Peroral Cholangioscopy Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones | |
Scientific Title:Acronym | Usefulness of Direct POC Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones | |
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Condition | ||
Condition | Y
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Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | In this study, we evaluated the usefulness of evaluation for BD using a DPOC with a multibending ultraslim endoscope after stone removal. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Diagnostic efficacy of direct POC for lesions difficult to be diagnosed by cholangiogram
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Key secondary outcomes | Risk factor for focal bile duct lesions difficult to be diagnosed by cholangiogram
Technical success rate of direct POC Technical success rate of direct POC-guided biopsy Diagnostic accuracy of direct POC-guided biopsy Technical success rate of direct POC-guided stone removal Total procedure time for direct POC Adverse events |
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 | Direct POC using a multibending ultra-slim endoscope
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Bile duct stones with dilated distal common bile duct more than 8 mm
2)Patients received balloon-occluded cholangiography for confirmation of ductal clearance after stone extraction 3)Previous sphincteroplasty |
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Key exclusion criteria | 1)Diffuse stricture on the distal common bile duct
2)Tumorous condition invading the bile duct or ampulla of Vater 3)Contraindication for ERCP 4)Bleeding tendency |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Department of Internal Medicine, SoonChunHyang University School of Medicine
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Division name | Digestive Disease Center and Research Institute, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea | ||||||
TEL | +82-32-621-5094 | ||||||
jhmoon@schmc.ac.kr |
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Name of contact person |
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Organization | SoonChunHyang University School of Medicine | ||||||
Division name | Digestive Disease Center and Research Institute, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma | ||||||
TEL | +82-32-621-5094 | ||||||
Homepage URL | |||||||
yunnah@schmc.ac.kr |
Sponsor | |
Institute | SoonChunHyang University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | SoonChunHyang University School of Medicine |
Organization | |
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Category of Funding Organization | Outside Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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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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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Management information | |||||||
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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=R000028829 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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