Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct StoneNCT04743089
Cost-Effectiveness of Spyglass Direct Visualization System Facilitated Management for the Patients With Intrahepatic Bile Duct Stone and/or Large Extrahepatic Bile Duct Stone
A study testing ERCP using SpyGlass™ DS Direct Visualization System and PTCS in people with Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct Stone, run by Yonsei University at 1 site in South Korea.
Trial summary
Endoscopic retrograde cholangio-pancreatectomy (ERCP) is the most commonly used endoscopic method for the treatment of biliary diseases including choledocholithiasis. When the ERCP cannot be performed under fluoroscopy due to various reasons such as the location of disease (i.e. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct Stone
- What is being tested?
- ERCP using SpyGlass™ DS Direct Visualization System and PTCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2020to Jan 2023
- 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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IHD stones disease that cannot be treated with the ERCP.
- Huge EHD stone disease that required mechanical/electrohydraulic lithotripsy, according to investigator's clinical decision.
Who cannot join
- Patients who disagree with the study
- Patients who underwent total gastrectomy
- Patients with IHD stones located in a peripheral IHD where spyglass cannot reach
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul
Moon Jae Chung, 82-2-2228-1981, mjchung@yuhs.ac
About this study
Endoscopic retrograde cholangio-pancreatectomy (ERCP) is the most commonly used endoscopic method for the treatment of biliary diseases including choledocholithiasis. When the ERCP cannot be performed under fluoroscopy due to various reasons such as the location of disease (i.e. intrahepatic bile duct lesion) and characteristics of the bile duct (i.e. altered anatomy, stenosis etc.), percutaneous transhepatic cholangiography (PTCS) is performed as an another treatment option. However, treatment of biliary lesions via PTCS requires at least 10 days of hospitalization for hepato-cutaneous fistula formation and tract epithelial maturation for the advancement of cholangioscope, which causes a significant financial burden as well as discomfort associated with fistula formation to the patients.
The SpyGlass™ DS Direct Visualization System (Boston Scientific Corp., Natick, Mass.) can be applied directly into the bile duct via the working channel of the duodenoscope. It can directly visualize the intra-ductal lesions with high-resolution digital imaging and it also has a working channel that allows the use of forcep, electrohydraulic lithotripsy (EHL) and Holmium Laser. So, it has the advantage of being able to directly examine intraductal lesions and perform treatment under the 'endoscopic view' which enables improved sensitivity of the diagnosis and the success rate of the treatment.
Read more
Intrahepatic duct (IHD) stone is difficult to treat by ERCP under fluoroscopy because IHD lesion is far from the orifice of bile duct (ampulla of Vater) and usually accompanied with IHD stenosis that causes technical difficulty. In addition, even if the stone is located in an extrahepatic bile duct (EHD; common hepatic duct and common bile duct), it is difficult to treat by ERCP in the case of a huge stone that has risk of incarceration. Therefore in these cases, bile duct stones have been being treated by PTCS. If the SpyGlass™ DS Direct Visualization System is used for the treatment of IHD/EHD stone that is not treatable with ERCP, it have potential benefits of reducing the financial burden and patient's discomfort caused by the PTCS significantly. Thus, we will investigate the usefulness of the SpyGlass™ DS Direct Visualization System for the treatment of IHD stones and huge EHD stones in terms of cost and success rate.
In this study, we will evaluate the treatment efficacy and cost-effectiveness of the SpyGlass™ DS Direct Visualization System facilitated management for IHD/EHD stones. The efficacy, cost-effectiveness and safety will be compared with historical cohort of percutaneous transhepatic cholangiography (PTCS)
- Being tested
- ERCP using SpyGlass™ DS Direct Visualization System, PTCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP using SpyGlass™ DS Direct Visualization SystemDevice
Lithotripsy and stone removal will be performed using ERCP and Spyglass system to patients with IHD/EHD stone, which is difficult to remove through conventional ERCP. The SpyGlass™ DS Direct Visualization System will be applied directly into the bile duct via the working channel of the duodenoscope. Under the high-resolution digital imaging, lithotripsy such as EHL could be done.
PTCSOther
A historical cohort of patients who underwent PTCS to remove bile duct stones which is difficult to treat by ERCP.
| Study group | Role | What they receive |
|---|---|---|
| Spyglass arm | Experimental | Patients who underwent IHD/EHD stone removal by ERCP with SpyGlass™ DS Direct Visualization System. Receives: Device: ERCP using SpyGlass™ DS Direct Visualization System |
| PTCS arm (historical cohort) | Other | Patients who underwent IHD/EHD stone removal by PTCS Receives: Other: PTCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hospital stay (# of days)
Total hospital day
Measured: from admission to 1 month after discharge
Total procedure-related cost
Total cost from the date of admission and until date of first out-patient clinic follow-up
Measured: from admission to 1 month after discharge
Secondary outcomes (2)
Efficacy; Technical success rate
successful complete stone removal
Measured: 1. after a month of ERCP procedure 2. after 3 months of ERCP procedure
Safety; Procedure-related complication rate
Measured: 1. after a month of ERCP procedure 2. after 3 months of ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start11 Dec 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (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 Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct StoneStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moon Jae Chung, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743089
- Sponsor's protocol ID
- 1-2018-0031
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin KI, Leem G, Koo J, Kim JH, Cho IR, Jo JH, Lee HS, Park JY, Bang S, Park SW, Chung MJ. SpyGlass Direct Visualization System: A Cost-Effective Approach Enhancing Nutritional and Immune Recovery in Difficult Bile Duct Stone Management. Yonsei Med J. 2026 Jun;67(6):466-476. doi: 10.3349/ymj.2025.0006.
PubMed 42198857
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of Spyglass Direct Visualization System Facilitated Management for the Patients With Intrahepatic Bile Duct Stone and/or Large Extrahepatic Bile Duct Stone
- ClinicalTrials.gov ID
- NCT04743089
- Acronym / sponsor ID
- 1-2018-0031
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 8 Feb 2021 (actual)
- 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.
Endoscopic retrograde cholangio-pancreatectomy (ERCP) is the most commonly used endoscopic method for the treatment of biliary diseases including choledocholithiasis. When the ERCP cannot be performed under fluoroscopy due to various reasons such as the location of disease (i.e. intrahepatic bile duct lesion) and characteristics of the bile duct (i.e. altered anatomy, stenosis etc.), percutaneous transhepatic cholangiography (PTCS) is performed as an another treatment option. However, treatment of biliary lesions via PTCS requires at least 10 days of hospitalization for hepato-cutaneous fistula formation and tract epithelial maturation for the advancement of cholangioscope, which causes a significant financial burden as well as discomfort associated with fistula formation to the patients.
The SpyGlass™ DS Direct Visualization System (Boston Scientific Corp., Natick, Mass.) can be applied directly into the bile duct via the working channel of the duodenoscope. It can directly visualize the intra-ductal lesions with high-resolution digital imaging and it also has a working channel that allows the use of forcep, electrohydraulic lithotripsy (EHL) and Holmium Laser. So, it has the advantage of being able to directly examine intraductal lesions and perform treatment under the 'endoscopic view' which enables improved sensitivity of the diagnosis and the success rate of the treatment.
Intrahepatic duct (IHD) stone is difficult to treat by ERCP under fluoroscopy because IHD lesion is far from the orifice of bile duct (ampulla of Vater) and usually accompanied with IHD stenosis that causes technical difficulty. In addition, even if the stone is located in an extrahepatic bile duct (EHD; common hepatic duct and common bile duct), it is difficult to treat by ERCP in the case of a huge stone that has risk of incarceration. Therefore in these cases, bile duct stones have been being treated by PTCS. If the SpyGlass™ DS Direct Visualization System is used for the treatment of IHD/EHD stone that is not treatable with ERCP, it have potential benefits of reducing the financial burden and patient's discomfort caused by the PTCS significantly. Thus, we will investigate the usefulness of the SpyGlass™ DS Direct Visualization System for the treatment of IHD stones and huge EHD stones in terms of cost and success rate.
In this study, we will evaluate the treatment efficacy and cost-effectiveness of the SpyGlass™ DS Direct Visualization System facilitated management for IHD/EHD stones. The efficacy, cost-effectiveness and safety will be compared with historical cohort of percutaneous transhepatic cholangiography (PTCS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spyglass arm | Experimental | Device: ERCP using SpyGlass™ DS Direct Visualization SystemPatients who underwent IHD/EHD stone removal by ERCP with SpyGlass™ DS Direct Visualization System. |
| PTCS arm (historical cohort) | Other | Other: PTCSPatients who underwent IHD/EHD stone removal by PTCS |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IHD stones disease that cannot be treated with the ERCP.
- Huge EHD stone disease that required mechanical/electrohydraulic lithotripsy, according to investigator's clinical decision.
Key exclusion criteria (3 listed)
- Patients who disagree with the study
- Patients who underwent total gastrectomy
- Patients with IHD stones located in a peripheral IHD where spyglass cannot reach
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 |
|---|---|---|
| ERCP using SpyGlass™ DS Direct Visualization SystemLithotripsy and stone removal will be performed using ERCP and Spyglass system to patients with IHD/EHD stone, which is difficult to remove through conventional ERCP. The SpyGlass™ DS Direct Visualization System will be applied directly into the bile duct via the working channel of the duodenoscope. Under the high-resolution digital imaging, lithotripsy such as EHL could be done. | Device | Spyglass arm |
| PTCSA historical cohort of patients who underwent PTCS to remove bile duct stones which is difficult to treat by ERCP. | Other | PTCS arm (historical cohort) |
Primary outcome
Total hospital stay (# of days)
Time frame: from admission to 1 month after discharge
Total hospital day
Total procedure-related cost
Time frame: from admission to 1 month after discharge
Total cost from the date of admission and until date of first out-patient clinic follow-up
2 secondary outcomes
Efficacy; Technical success rate
Time frame: 1. after a month of ERCP procedure 2. after 3 months of ERCP procedure
Safety; Procedure-related complication rate
Time frame: 1. after a month of ERCP procedure 2. after 3 months of ERCP procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Derived from this study: PubMed 42198857Shin KI, Leem G, Koo J, Kim JH, Cho IR, Jo JH, Lee HS, Park JY, Bang S, Park SW, Chung MJ. SpyGlass Direct Visualization System: A Cost-Effective Approach Enhancing Nutritional and Immune Recovery in Difficult Bile Duct Stone Management. Yonsei Med J. 2026 Jun;67(6):466-476. doi: 10.3349/ymj.2025.0006.
- Individual participant dataSharing planned: No
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.
Moon Jae Chung principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP using SpyGlass™ DS Direct Visualization System and PTCS in people with Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct Stone, run by Yonsei University 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 2 inclusion and 3 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 8 Feb 2021. 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?
Contact Moon Jae Chung (82-2-2228-1981, mjchung@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total hospital stay (# of days) (time frame: from admission to 1 month after discharge). The study lists 2 primary outcomes in all. 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 NCT04743089, 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 8 Feb 2021.