post-liver transplant BD strictures A clinical suspicion of post-liver transplant bile duct stricture(s). Biliary complications in post-liver transplant
Conditions
Interventions
None listed
Sponsors
Boston Scientific Corporation
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Liver transplantation at least 1 month prior to POCS procedure 2. Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms 3. Prior cross-sectional imaging (MRI and/or US and/or CT) 4. Suspected anastomotic biliary stricture(s) 5. Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging. 6. Willing and able to provide a written informed consent to participate in the study 7. Willing and able to comply with study procedures and follow-up schedule
Exclusion criteria
Exclusion criteria: 1. Contraindication for an ERCP per local standard of practice 2. Contraindication for POCS per local standard of practice 3. Prior treatment of biliary anastomotic stricture 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications. • Recommended management options based on ERCP alone will be recorded immediately following the ERCP and before starting the POCS portion of the procedure; recommended management options based on ERCP and POCS combined will be recorded immediately following the POCS procedure. • Success is defined as different recommended management options based on ERCP alone versus on ERCP and POCS combined. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be recorded as secondary outcomes during baseline and follow-up procedures: 1) Technical success: Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology. 2) Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations. 3) Number and type of biliary re-interventions. Re-interventions may include but are not limited to repeat ERCP, repeat POCS, ultrasonography, stent exchanges, balloon dilations and liver biopsy. 4) Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate. Confirmation of adequacy of patient management may be based on one or more of the following: • Resolution of symptoms • Improvement of LFTs compared to baseline • Confirmation of resolution of biliary complication with US/CT/MRI/MRCP imaging • Absence of unscheduled re-interventions during follow-up • Absence of SAEs during the follow-up period related to the original findings on POCS • Free passage of balloon sweep > 8-10mm 5) Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up. 6) Evaluation of surgeon of whether or not POCS impacted patient management post procedure. | — |
Countries
Netherlands
Outcome results
None listed