Clinical Usefulness of Digital Single-operator Cholangioscopy(SpyGlass™) for Post-liver Transplant Anastomotic Stricture

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.

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 Overview

• Status: Recruiting
• Conditions: Liver Transplant; Complications; Biliary Duct Obstruction; Anastomosis, Obstructed
• Intervention / Treatment: Device: digital single-operator cholangioscopy

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sang Hyub Lee, MD, PhD; Phone Number: 82-2072-2228; Email: gidoctor@snuh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

LDLT patients with anastomotic biliary stricture

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LDLT cohort; Living-donor liver transplatation (LDLT) patients with anastomotic biliary stricture	Device: digital single-operator cholangioscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During endoscopic treatment (ERCP with SpyGlass)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Clinical success	Rate of improvement of abdominal pain, obstructive jaundice or infection at one month after treatment	after a month of ERCP procedure
Rate of Complication rate	post-procedural cholangitis, pancreatitis, bleeding, or perforation	after a month of ERCP procedure
Rate of Recurrence rate	re-intervention within 1 month	after a month of ERCP procedure

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: H-2105-134-1219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No