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

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ClinicalTrials.gov Identifier: NCT05065125
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital

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.


Condition or disease Intervention/treatment
Liver Transplant; Complications Biliary Duct Obstruction Anastomosis, Obstructed Device: digital single-operator cholangioscopy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Clinical Usefulness of Digital Single-operator Cholangioscopy (SpyGlass™) for Post-liver Transplant Anastomotic Stricture
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. Rate of Clinical success [ Time Frame: after a month of ERCP procedure ]
    Rate of improvement of abdominal pain, obstructive jaundice or infection at one month after treatment

  2. Rate of Complication rate [ Time Frame: after a month of ERCP procedure ]
    post-procedural cholangitis, pancreatitis, bleeding, or perforation

  3. Rate of Recurrence rate [ Time Frame: after a month of ERCP procedure ]
    re-intervention within 1 month



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
LDLT patients with anastomotic biliary stricture
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065125


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Sang Hyub Lee, MD, PhD    82-2072-2228    gidoctor@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Sang Hyub Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05065125    
Other Study ID Numbers: H-2105-134-1219
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical