Common Bile Duct CalculiNCT02189421
Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy
A study testing ultra-slim upper endoscope in people with Common Bile Duct Calculi and Biliary Tract Cancer, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Common Bile Duct Calculi, Biliary Tract Cancer, Biliary Stricture
- What is being tested?
- ultra-slim upper endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Bucheon Hospital
Bucheon-si, 420-767
About this study
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
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.
Read the 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.
- Being tested
- ultra-slim upper endoscope
- Keywords
- peroral cholangioscopy, ultra-slim upper endoscope, multibending endoscope
- Medical subject headings
- Gallstones, Biliary Tract Neoplasms, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-slim upper endoscopeDevice
Also called CHF-Y0009, GIF-XP290N
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
| Study group | Role | What they receive |
|---|---|---|
| Direct peroral cholangioscopy | Other | Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories Receives: Device: ultra-slim upper endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the direct peroral cholangioscopy
Successful insertion of a slim endoscope into the bile duct in no assisting accessories.
Measured: 6 months
Secondary outcomes (1)
Adverse events associated with direct POC
- 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jong Choi, Soonchunhyang University Hospital
- Investigators
- Jong Ho Moon, MD, PhD, Principal investigator, Soonchunhyang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189421
- Sponsor's protocol ID
- SCHBC 2014-06-012-001
- Status last verified
- Oct 2015
- First submitted
- 9 Jul 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee YN, Moon JH, Lee TH, Choi HJ, Itoi T, Beyna T, Neuhaus H. Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video). Gastrointest Endosc. 2020 Jan;91(1):92-101. doi: 10.1016/j.gie.2019.08.007. Epub 2019 Aug 20.
PubMed 31442395
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02189421
- Acronym / sponsor ID
- SCHBC 2014-06-012-001
- Keywords
- peroral cholangioscopy, ultra-slim upper endoscope, multibending endoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Feb 2016 (estimated)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct peroral cholangioscopy | Other | Device: ultra-slim upper endoscopeDirect peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultra-slim upper endoscopeAlso: CHF-Y0009, GIF-XP290NDirect peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories | Device | Direct peroral cholangioscopy |
Primary outcome
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.
1 secondary outcome
Adverse events associated with direct POC
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Derived from this study: PubMed 31442395Lee YN, Moon JH, Lee TH, Choi HJ, Itoi T, Beyna T, Neuhaus H. Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video). Gastrointest Endosc. 2020 Jan;91(1):92-101. doi: 10.1016/j.gie.2019.08.007. Epub 2019 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Ho Moon, MD, PhD principal investigator
Soonchunhyang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultra-slim upper endoscope in people with Common Bile Duct Calculi and Biliary Tract Cancer, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the direct peroral cholangioscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.