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Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy

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ClinicalTrials.gov Identifier: NCT02189421
Recruitment Status : Unknown
Verified October 2015 by Hyun Jong Choi, Soonchunhyang University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hyun Jong Choi, Soonchunhyang University Hospital

Study Description
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Brief Summary:
The aim of this study is to evaluate the usefulness of a newly developed multibending ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without assisting accessory in comparison with conventional ultra-slim endoscope. The investigators expect that multibending endoscope will show more higher successful performance than conventional endoscope.

Condition or disease Intervention/treatment Phase
Common Bile Duct Calculi Biliary Tract Cancer Biliary Stricture Bile Duct Diseases Device: ultra-slim upper endoscope Not Applicable

Detailed Description:
Direct POC using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic intraductal interventions under direct endoscopic visualization in selected patients who has dilated distal CBD and widened papillary orifice. Because the bile duct has anatomical position in acute angle with the duodenum, assisting accessories such as intraductal anchoring balloon, guidewire or overtube is usually required for the successful direct POC. Recently, direct peroral cholangioscopes have been developed for free-hand direct advancement of the endoscope into the bile duct from duodenum. Multibending ultra-slim endoscope may be expected to facilitate the advance into the bile duct by overcoming the acute angle between the bile duct and the duodenum. After randomization of enrolled patients into two groups, direct POC will be performed by using a conventional slim endoscope in control group and by using a multibending endoscope in study group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Comparison of Multibending and Conventional Ultra-slim Upper Endoscope for the Direct Advance Into the Bile Duct Without Assisting Accessory in Peroral Cholangioscopy
Study Start Date : April 2014
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : February 2016

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Arms and Interventions
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Arm Intervention/treatment
Direct peroral cholangioscopy
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
 Device: ultra-slim upper endoscope
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
Other Names:
  • CHF-Y0009
  • GIF-XP290N


Outcome Measures
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Primary Outcome Measures :
  1. Technical success of the direct peroral cholangioscopy [ Time Frame: 6 months ]
    Successful insertion of a slim endoscope into the bile duct in no assisting accessories.


Secondary Outcome Measures :
  1. Adverse events associated with direct POC [ Time Frame: 6 months ]
    1. Cholangitis: fever and abdominal pain with abnormal liver function test
    2. Hemobilia: bleeding from the bile duct
    3. Pancreatitis: abdominal pain with elevation of the serum amylase and lipase
    4. Bile duct perforation: any evidence of bile duct perforation in imaging studies.
    5. Air embolism: clinical and imagine findings with air embolism


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pancreatobiliary diseases that are indicated for direct POC
  • The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
  • The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
  • Dilated common bile duct (> 8 mm)
  • Having previous sphincterotomy and/or papillary balloon dilation
  • The patients should not have any unacceptable conditions (e.g., physiological, familyish, social, geographical) for medical follow-up and adaptation of the study.

Exclusion Criteria:

  • Contraindicated for ERCP
  • Patients with stricture on papillary orifice
  • Patients with periampullary malignancy
  • Bleeding tendency: International normalized ratio (INR) of prothrombin time < 1.5 or platelet count < 60,000/mm3
  • Patients with other serious disease or medical condition
  • Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
  • Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
Contacts and Locations
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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): NCT02189421


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, MD, PhD SoonChunHyang University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hyun Jong Choi, Assistant professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02189421    
Other Study ID Numbers: SCHBC 2014-06-012-001
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Keywords provided by Hyun Jong Choi, Soonchunhyang University Hospital:
peroral cholangioscopy
ultra-slim upper endoscope
multibending endoscope
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Bile Duct Diseases
Gallstones
Calculi
Pathological Conditions, Anatomical
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis
Cholecystolithiasis
Gallbladder Diseases