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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

Study Description
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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.

Condition or disease
Bile Duct Stricture Choledocholithiasis

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope
Study Start Date : August 2006
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016
Groups and Cohorts
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Group/Cohort
Direct peroral cholangioscopy
Patients with bile duct disease that is eligible to direct peroral cholangioscopy


Outcome Measures
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Primary Outcome Measures :
  1. Success rate [ Time Frame: Within 24 hours after Completion of DPOC ]
    Advance of an ultra-slim endoscope into the hilar portion or stricture


Secondary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: Up to 10 days after completion of DPOC ]
    Diagnostic accuracy for bile duct diseases

  2. 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

  3. Complication [ Time Frame: Within 30 days after DPOC ]
    cholangitis, pancreatitis, hemobilia, perforation, air embolism or mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Refered or inpatients of tertiary medical center
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276157


Locations
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Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of, 420-767
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Jong Ho Moon, M.D., Ph.D. SoonChunHyang University School of Medicine
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Jong Ho Moon, Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02276157    
Other Study ID Numbers: 2014-07-026
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Keywords provided by Jong Ho Moon, Soonchunhyang University Hospital:
cholangioscopy
Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
 Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis