NCT02276157

Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Bile Duct Stricture
• Choledocholithiasis

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-01-01
• Completion: 2017-11-01
• First posted: 2014-10-28
• Last updated: 2022-10-31

Locations

1 site across 1 country: South Korea