Clinical Trial: Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

Brief Summary: This study was aimed to evaluate of the success rate and clinical usefulness of direct peroral cholangioscopy by using an ultra-slim upper endoscope for the diagnosis and treatment of bile duct diseases.

Detailed Summary: Direct peroral cholangioscopy (DPOC) by using an ultra-slim upper endoscope provides optical endoscopic images of bile duct and permits various diagnostic or therapeutic intraductal interventions. Usually assisting accessories such as balloon catheter is demanded for an endoscope to advance into the bile duct. Possible diagnostic applications of DPOC include evaluation of indeterminate bile duct strictures, precise mapping and delineation of intraductal tumor spread before resection, differentiation of benign versus malignant intraductal masses, evaluation of ductal ischemia after liver transplant and confirmation of bile duct clearance after endoscopic stone removal. And therapeutic applications of DPOC include intraductal lithotripsy, intraductal tumor ablation therapy by argon plasma coagulation, photodynamic therapy or radiofrequency ablation, direct stone or migrated stent removal, selective guidewire access, and biliary drainage. The investigators evaluated the success rate by useful accessories and various diagnostic and therapeutic intraductal procedures under DPOC.
Sponsor: Soonchunhyang University Hospital

Current Primary Outcome: Success rate [ Time Frame: Within 24 hours after Completion of DPOC ]

Advance of an ultra-slim endoscope into the hilar portion or stricture


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Diagnostic accuracy [ Time Frame: Up to 10 days after completion of DPOC ]
    Diagnostic accuracy for bile duct diseases
  • Success rate of therapeutic procedures under DPOC [ Time Frame: Within 24 hours after Completion of DPOC ]
    Maintenance of the endoscope position until the successful therapy under DPOC
  • Complication [ Time Frame: Within 30 days after DPOC ]
    cholangitis, pancreatitis, hemobilia, perforation, air embolism or mortality


Original Secondary Outcome: Same as current

Information By: Soonchunhyang University Hospital

Dates:
Date Received: October 21, 2014
Date Started: August 2006
Date Completion: December 2016
Last Updated: April 19, 2016
Last Verified: April 2016