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The aim of this study is to evaluate the usefulness of a newly developed multibending ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without assisting accessory in comparison with conventional ultra-slim endoscope. The investigators expect that multibending endoscope will show more higher successful performance than conventional endoscope.
Direct POC using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic intraductal interventions under direct endoscopic visualization in selected patients who has dilated distal CBD and widened papillary orifice. Because the bile duct has anatomical position in acute angle with the duodenum, assisting accessories such as intraductal anchoring balloon, guidewire or overtube is usually required for the successful direct POC. Recently, direct peroral cholangioscopes have been developed for free-hand direct advancement of the endoscope into the bile duct from duodenum. Multibending ultra-slim endoscope may be expected to facilitate the advance into the bile duct by overcoming the acute angle between the bile duct and the duodenum. After randomization of enrolled patients into two groups, direct POC will be performed by using a conventional slim endoscope in control group and by using a multibending endoscope in study group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct peroral cholangioscopy | Other | Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultra-slim upper endoscope | Device | Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of the direct peroral cholangioscopy | Successful insertion of a slim endoscope into the bile duct in no assisting accessories. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events associated with direct POC |
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Ho Moon, MD, PhD | Soonchunhyang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | 420-767 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31442395 | Derived | Lee YN, Moon JH, Lee TH, Choi HJ, Itoi T, Beyna T, Neuhaus H. Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video). Gastrointest Endosc. 2020 Jan;91(1):92-101. doi: 10.1016/j.gie.2019.08.007. Epub 2019 Aug 20. |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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|
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |