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
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|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|
Living-donor liver transplatation (LDLT) patients with anastomotic biliary stricture
Device: digital single-operator cholangioscopy
- 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).
- 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
- Rate of Complication rate [ Time Frame: after a month of ERCP procedure ]post-procedural cholangitis, pancreatitis, bleeding, or perforation
- Rate of Recurrence rate [ Time Frame: after a month of ERCP procedure ]re-intervention within 1 month
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
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 03080|
|Contact: Sang Hyub Lee, MD, PhD 82-2072-2228 firstname.lastname@example.org|