Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-11-30

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.

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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.

Conditions

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Bile Duct Stricture Choledocholithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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MB group

Direct POC performed with third-generation prototype multibending ultra-slim endoscope (CHF-Y0010; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)

Group Type EXPERIMENTAL

Direct peroral cholangioscopy

Intervention Type DEVICE

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.

Conventional group

Direct POC performed with conventional ultra-slim endoscope (GIF-XP290N; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)

Group Type ACTIVE_COMPARATOR

Direct peroral cholangioscopy

Intervention Type DEVICE

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.

Interventions

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Direct peroral cholangioscopy

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No