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Completed

NCT Number: NCT02276157

Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

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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Key information

Conditions

Bile Duct Stricture Bile Duct Diseases Biliary Tract Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soonchunhyang University Bucheon Hospital

Bucheon-si, 420-767, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct peroral cholangioscopy

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.

Primary outcomes

  1. The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC

    Time frame: within 15 min after insertion of endoscope into the mouth

    successful insertion of the endoscope through the AOV and advancement up to the bifurcation or obstructed segment of the biliary tree, without any accessories

Secondary outcomes

  1. Procedure time required for free-hand insertion

    Time frame: 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

    Procedure time required for free-hand insertion

  2. The technical success of diagnostic and therapeutic interventions

    Time frame: Within 24 hours after Completion of DPOC

    The technical success of diagnostic and therapeutic interventions

  3. Adverse events related to direct POC

    Time frame: Within 7 days after DPOC

    perforation, cholangitis, pancreatitis, and air embolism

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2014
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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