Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

Study Overview
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Brief Summary
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This study was aimed to to evaluate the efficacy of the new multibending ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC.

Detailed Description
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Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, the investigators evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories. The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, which was defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 min.

Official Title
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A Prospective Randomized Trial of a New Multibending Versus Conventional Ultra-slim Endoscope for Direct Peroral Cholangioscopy Without Device Assistance

Conditions
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Bile Duct Stricture, Choledocholithiasis

Intervention / Treatment
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* Device: Direct peroral cholangioscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: biliary disease requiring diagnostic and/or therapeutic direct POC distal common bile duct (CBD) dilation > 8 mm previous sphincteroplasty, including major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation during a prior ERCP ability to provide informed consent Exclusion Criteria: presence of any contraindication to ERCP bleeding tendency (international normalized ratio > 1.5 or platelet count < 50,000/ mm3) diffuse stricture of the distal CBD diagnosis of pancreatic cancer or tumor at the ampulla of Vater (AOV) altered gastrointestinal anatomy or significant duodenal obstruction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB group<br>Direct POC performed with third-generation prototype multibending ultra-slim endoscope (CHF-Y0010; Olympus Medical Systems, Co., Ltd., Tokyo, Japan) | Device: Direct peroral cholangioscopy<br>* The multibending (MB) or conventional ultra-slim endoscope was inserted through the mouth. After facing the papillary orifice, the endoscope was inserted directly, without any accessories, into the distal bile duct. The second bending of the MB ultra-slim endoscope was kept in an upward angled position to achieve a more acute angle of the endoscope tip for entering the distal CBD. Then, the endoscope was pushed by steering the first bend into an upward angle (α shape) or the endoscope was pulled by steering the first bend into an upward angle and torqueing it counter-clockwise (u shape) for insertion into the distal CBD. If the distal bile duct was visualized on an endoscopic view, carbon dioxide insufflation was stopped. The endoscope was advanced into the hilum or the obstructed segment of the extrahepatic bile duct under fluoroscopic and endoscopic control. Then, the diagnostic and therapeutic interventions were performed during direct POC as necessary.<br>|
| Active Comparator: Conventional group<br>Direct POC performed with conventional ultra-slim endoscope (GIF-XP290N; Olympus Medical Systems, Co., Ltd., Tokyo, Japan) | Device: Direct peroral cholangioscopy<br>* The multibending (MB) or conventional ultra-slim endoscope was inserted through the mouth. After facing the papillary orifice, the endoscope was inserted directly, without any accessories, into the distal bile duct. The second bending of the MB ultra-slim endoscope was kept in an upward angled position to achieve a more acute angle of the endoscope tip for entering the distal CBD. Then, the endoscope was pushed by steering the first bend into an upward angle (α shape) or the endoscope was pulled by steering the first bend into an upward angle and torqueing it counter-clockwise (u shape) for insertion into the distal CBD. If the distal bile duct was visualized on an endoscopic view, carbon dioxide insufflation was stopped. The endoscope was advanced into the hilum or the obstructed segment of the extrahepatic bile duct under fluoroscopic and endoscopic control. Then, the diagnostic and therapeutic interventions were performed during direct POC as necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC | successful insertion of the endoscope through the AOV and advancement up to the bifurcation or obstructed segment of the biliary tree, without any accessories | within 15 min after insertion of endoscope into the mouth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time required for free-hand insertion | Procedure time required for free-hand insertion | the time of oral intubation with the ultra-slim endoscope to the time of reaching the obstructed segment of the biliary tree or bifurcation, within 15 min after insertion of endoscope into the mouth | 
| The technical success of diagnostic and therapeutic interventions | The technical success of diagnostic and therapeutic interventions | Within 24 hours after Completion of DPOC | 
| Adverse events related to direct POC | perforation, cholangitis, pancreatitis, and air embolism | Within 7 days after DPOC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholangioscopy