Unique ID issued by UMIN | UMIN000020465 |
---|---|
Receipt number | R000023647 |
Scientific Title | SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy as a Single-Operator Peroral Cholangioscopy for the Managing Biliary Lesions: a Prospective Comparative Study |
Date of disclosure of the study information | 2017/08/26 |
Last modified on | 2016/01/06 23:10:26 |
SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy as a Single-Operator Peroral Cholangioscopy for the Managing Biliary Lesions: a Prospective Comparative Study
SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy for the Managing Biliary Lesions
SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy as a Single-Operator Peroral Cholangioscopy for the Managing Biliary Lesions: a Prospective Comparative Study
SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy for the Managing Biliary Lesions
Asia(except Japan) |
Biliary diseases
Gastroenterology |
Others
NO
To compare the procedure success rate of POC using SpyGlass DVS and Direct POC using a mutibending ultraslim endoscope for diagnosis and treatment of bile duct diseases
Safety,Efficacy
Procedure success rate
Technical success rate
Procedure success rate according to the type of lesion
Success rate of diagnostic and therapeutic procedure
Total procedure time for SOCs
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Diagnosis
Device,equipment |
SOC using SpyGlass DVS
SOC using direct POC
18 | years-old | <= |
90 | years-old | > |
Male and Female
Biliary diseases indicated for SOC
Previous sphincteroplasty (i.e. EST, EPBD)
Dilated distal CBD>8mm
Diffuse stricture on the distal CBD
Periampullary cancer
Contraindication for endoscopic procedure
Bleeding tendency (INR>1.5 or platelet count < 60,000/mm3)
25
1st name | |
Middle name | |
Last name | Jong Ho Moon |
SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute, Department of Internal Medicine
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
+82-32-621-5094
jhmoon@schmc.ac.kr
1st name | |
Middle name | |
Last name | Yun Nah Lee |
Department of Internal Medicine, Soon Chun Hyang University School of Medicine
Digestive Disease Center and Research Institute, Department of Internal Medicine
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
+82-32-621-5094
yunnah@schmc.ac.kr
SoonChunHyang University School of Medicine
none
Other
NO
2017 | Year | 08 | Month | 26 | Day |
Unpublished
Suspended
2015 | Year | 03 | Month | 01 | Day |
2015 | Year | 03 | Month | 02 | Day |
2016 | Year | 01 | Month | 06 | Day |
2016 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023647
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |