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Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

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ClinicalTrials.gov Identifier: NCT02276157
Recruitment Status : Unknown
Verified April 2016 by Jong Ho Moon, Soonchunhyang University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : October 28, 2014
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Jong Ho Moon, Soonchunhyang University Hospital

Tracking Information
First Submitted Date October 21, 2014
First Posted Date October 28, 2014
Last Update Posted Date April 20, 2016
Study Start Date August 2006
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 23, 2014)
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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 23, 2014)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope
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 Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Refered or inpatients of tertiary medical center
Condition
  • Bile Duct Stricture
  • Choledocholithiasis
Intervention Not Provided
Study Groups/Cohorts Direct peroral cholangioscopy
Patients with bile duct disease that is eligible to direct peroral cholangioscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 23, 2014)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with bile duct diseases
  • Dilated common bile duct (> 8mm)
  • Having previous sphincteroplasty by endoscopic sphincterotomy and/or papillary balloon dilation

Exclusion Criteria:

  • Periampullary malignancies
  • Severe stricture on papillary orifice
  • Bleeding tendency
  • Contraindications for endoscopic retrograde cholangiopancreatography
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02276157
Other Study ID Numbers 2014-07-026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jong Ho Moon, Soonchunhyang University Hospital
Study Sponsor Soonchunhyang University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jong Ho Moon, M.D., Ph.D. SoonChunHyang University School of Medicine
PRS Account Soonchunhyang University Hospital
Verification Date April 2016