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

NCT05065125 | Unknown

• 1 other identifier: H-2105-134-1219
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Transplant; Complications; Biliary Duct Obstruction; Anastomosis, Obstructed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of Clinical success

  after a month of ERCP procedure

• Rate of Complication rate

  after a month of ERCP procedure

• Rate of Recurrence rate

  after a month of ERCP procedure

Study Arms (1)

LDLT cohort

Living-donor liver transplatation (LDLT) patients with anastomotic biliary stricture

Device: digital single-operator cholangioscopy

Interventions

digital single-operator cholangioscopy DEVICE

1. 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.

LDLT cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

LDLT patients with anastomotic biliary stricture

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 39557203 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: October 5, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

KR (1)