Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
Korea, Republic of | |
Soonchunhyang University Bucheon Hospital | |
Bucheon, Korea, Republic of, 420-767 |
Principal Investigator: | Jong Ho Moon, MD, PhD | SoonChunHyang University School of Medicine |
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 |
peroral cholangioscopy ultra-slim upper endoscope multibending endoscope |
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 |