Liver Transplant; ComplicationsNCT05065125
Clinical Usefulness of Digital Single-operator Cholangioscopy(SpyGlass™) for Post-liver Transplant Anastomotic Stricture
An observational study of Liver Transplant; Complications and Biliary Duct Obstruction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Liver transplantation (LT) is an essential treatment for end-stage liver disease. Although clinical outcomes of LT recipients have markedly improved, anastomotic biliary strictures (ABS) are still occurred in 10-40% of post-LT patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Liver Transplant; Complications, Biliary Duct Obstruction, Anastomosis, Obstructed
- What is being tested?
- digital single-operator cholangioscopy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2021to Dec 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: LDLT patients with anastomotic biliary stricture
Who may be able to join
- Age 19 or older
- Patients who treated with LDLT (Duct-to-duct anastomosis)
- Patients with confirmed anastomosis site biliary stricture using cross-sectional imaging study (CT, MRI/MRCP).
Who cannot join
- Patients with age 18 or under
- Pregnant woman
- Patients unable to endoscopic (transpapillary) approach due to prior surgical history
- Patients who did not provide informed consent to participation in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sang Hyub Lee, MD, PhD, 82-2072-2228, gidoctor@snuh.org
About this study
Official title: Clinical Usefulness of Digital Single-operator Cholangioscopy (SpyGlass™) for Post-liver Transplant Anastomotic Stricture
Liver transplantation (LT) is an essential treatment for end-stage liver disease. Although clinical outcomes of LT recipients have markedly improved, anastomotic biliary strictures (ABS) are still occurred in 10-40% of post-LT patients.
In the Korea, living donor LT (LDLT) is the more common than deceased donor LT (DDLT). When LDLT is performed, the right lobe graft is usually used, and the right anterior and posterior segmental bile ducts (RASD/RPSD) of the graft are reconstructed by the duct-to-duct anastomosis method to the common hepatic duct of the recipient.
Read more
When ABS occurs in LDLT recipients, the stricture site is often very tight and twisted. So, conventional endoscopic procedure is challenging and success rate of ERCP for ABS is still unsatisfactory (about 60%). Furthermore, approach to the RPSD is more intricate than that to RASD because the duct opening is located deeper in a posterior aspect. Therefore, despite being able to benefit the patient, bilateral drainage (both RASD and RPSD) is considered to be more difficult and unilateral drainage of RASD is mainly performed.
In 2015, high-resolution cholangioscopy (SpyGlass™) was introduced. The system enables direct visualization of the bile and pancreatic ducts strictures. The 3rd Generation SpyScope DS II Access \& Delivery Catheter introduced in 2018, features increased resolution and adjusted lighting to provide physicians with an even better view of the biliary and pancreatic ducts. To date, only several retrospective studies have evaluated the efficacy of SpyGlass for guidewire placement across the ABS and to the best of our knowledge only one prospective study is ongoing (ClinicalTrials.gov NCT #03205072). In that study ABS in both LDLT and DDLT patients are enrolled. Private communications with the Sponsor of this study, however, have reported that only approximately 10% of the cases are LDLT cases. In addition, there is no reported paper about the usefulness of Spyglass for bilateral drainage and its clinical benefit in post LT ABS.
If successful bilateral drainage is performed by using Spyglass, it may be more helpful for patients than unilateral drainage as it allows sufficient drainage of the transplanted liver. With this prospective study, we intends to investigate the efficacy of Spyglass for bilateral drainage of ABS in LDLT patients and improve drainage success rate. This results can be used as clinical basis for further studies such as randomized controlled trial.
- Being tested
- digital single-operator cholangioscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital single-operator cholangioscopyDevice
- Duodenoscope passes through esophagus and stomach to the papilla of Vater
- SpyScope DS Catheter passes through the duodenoscope and into common bile duct
- After direct visualization of anastomosis site stricture, guidewire is passed through SpyScope DS Catheter above the stricture site.
| Study group | Role | What they receive |
|---|---|---|
| LDLT cohort | Living-donor liver transplatation (LDLT) patients with anastomotic biliary stricture Receives: Device: digital single-operator cholangioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Technical success
① Successful guidewire placement across the stricture site or
② Successful subsequent treatment (advancement of dilatation balloon and/or placement of biliary endoprosthesis across the stricture when intended).
Measured: During endoscopic treatment (ERCP with SpyGlass)
Secondary outcomes (3)
Rate of Clinical success
Rate of improvement of abdominal pain, obstructive jaundice or infection at one month after treatment
Measured: after a month of ERCP procedure
Rate of Complication rate
post-procedural cholangitis, pancreatitis, bleeding, or perforation
Measured: after a month of ERCP procedure
Rate of Recurrence rate
re-intervention within 1 month
Measured: after a month 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 posted1 Oct 2021
- Study start5 Oct 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (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 Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065125
- Sponsor's protocol ID
- H-2105-134-1219
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho IR, Lee SH, Kang J, Kim J, Lee TS, Lee MH, Lee MW, Choi JH, Paik WH, Ryu JK, Kim YT, Hong SK, Choi Y, Yi NJ, Lee KW, Suh KS. Digital single-operator cholangioscopy for difficult anastomotic biliary strictures in living donor liver transplant recipients after failure of standard ERCP: SPYPASS-2 study (with videos). Gastrointest Endosc. 2025 May;101(5):979-987.e3. doi: 10.1016/j.gie.2024.11.017. Epub 2024 Nov 16.
PubMed 39557203
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Digital Single-operator Cholangioscopy (SpyGlass™) for Post-liver Transplant Anastomotic Stricture
- ClinicalTrials.gov ID
- NCT05065125
- Acronym / sponsor ID
- H-2105-134-1219
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Oct 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.
Liver transplantation (LT) is an essential treatment for end-stage liver disease. Although clinical outcomes of LT recipients have markedly improved, anastomotic biliary strictures (ABS) are still occurred in 10-40% of post-LT patients.
In the Korea, living donor LT (LDLT) is the more common than deceased donor LT (DDLT). When LDLT is performed, the right lobe graft is usually used, and the right anterior and posterior segmental bile ducts (RASD/RPSD) of the graft are reconstructed by the duct-to-duct anastomosis method to the common hepatic duct of the recipient.
When ABS occurs in LDLT recipients, the stricture site is often very tight and twisted. So, conventional endoscopic procedure is challenging and success rate of ERCP for ABS is still unsatisfactory (about 60%). Furthermore, approach to the RPSD is more intricate than that to RASD because the duct opening is located deeper in a posterior aspect. Therefore, despite being able to benefit the patient, bilateral drainage (both RASD and RPSD) is considered to be more difficult and unilateral drainage of RASD is mainly performed.
In 2015, high-resolution cholangioscopy (SpyGlass™) was introduced. The system enables direct visualization of the bile and pancreatic ducts strictures. The 3rd Generation SpyScope DS II Access \& Delivery Catheter introduced in 2018, features increased resolution and adjusted lighting to provide physicians with an even better view of the biliary and pancreatic ducts. To date, only several retrospective studies have evaluated the efficacy of SpyGlass for guidewire placement across the ABS and to the best of our knowledge only one prospective study is ongoing (ClinicalTrials.gov NCT #03205072). In that study ABS in both LDLT and DDLT patients are enrolled. Private communications with the Sponsor of this study, however, have reported that only approximately 10% of the cases are LDLT cases. In addition, there is no reported paper about the usefulness of Spyglass for bilateral drainage and its clinical benefit in post LT ABS.
If successful bilateral drainage is performed by using Spyglass, it may be more helpful for patients than unilateral drainage as it allows sufficient drainage of the transplanted liver. With this prospective study, we intends to investigate the efficacy of Spyglass for bilateral drainage of ABS in LDLT patients and improve drainage success rate. This results can be used as clinical basis for further studies such as randomized controlled trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDLT cohort | – | Device: digital single-operator cholangioscopyLiving-donor liver transplatation (LDLT) patients with anastomotic biliary stricture |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- LDLT patients with anastomotic biliary stricture
Key inclusion criteria (3 listed)
- Age 19 or older
- Patients who treated with LDLT (Duct-to-duct anastomosis)
- Patients with confirmed anastomosis site biliary stricture using cross-sectional imaging study (CT, MRI/MRCP).
Key exclusion criteria (4 listed)
- Patients with age 18 or under
- Pregnant woman
- Patients unable to endoscopic (transpapillary) approach due to prior surgical history
- Patients who did not provide informed consent to participation in the study
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 |
|---|---|---|
| digital single-operator cholangioscopy1. Duodenoscope passes through esophagus and stomach to the papilla of Vater 2. SpyScope DS Catheter passes through the duodenoscope and into common bile duct 3. After direct visualization of anastomosis site stricture, guidewire is passed through SpyScope DS Catheter above the stricture site. | Device | LDLT cohort |
Primary outcome
Rate of Technical success
Time frame: During endoscopic treatment (ERCP with SpyGlass)
① Successful guidewire placement across the stricture site or ② Successful subsequent treatment (advancement of dilatation balloon and/or placement of biliary endoprosthesis across the stricture when intended).
3 secondary outcomes
Rate of Clinical success
Time frame: after a month of ERCP procedure
Rate of Complication rate
Time frame: after a month of ERCP procedure
Rate of Recurrence rate
Time frame: after a month 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 21 Oct 2021.
- Derived from this study: PubMed 39557203Cho IR, Lee SH, Kang J, Kim J, Lee TS, Lee MH, Lee MW, Choi JH, Paik WH, Ryu JK, Kim YT, Hong SK, Choi Y, Yi NJ, Lee KW, Suh KS. Digital single-operator cholangioscopy for difficult anastomotic biliary strictures in living donor liver transplant recipients after failure of standard ERCP: SPYPASS-2 study (with videos). Gastrointest Endosc. 2025 May;101(5):979-987.e3. doi: 10.1016/j.gie.2024.11.017. Epub 2024 Nov 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Biliary Duct Obstruction, run by Seoul National 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 3 inclusion and 4 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 21 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Technical success (time frame: During endoscopic treatment (ERCP with SpyGlass)). 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 NCT05065125, 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 21 Oct 2021.