Liver Transplant; Complications
Conditions
Keywords
ERCP, Per-Oral Cholangioscopy, Liver Transplantation, Spy Glass
Brief summary
A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.
Detailed description
The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.
Interventions
DEVICESpy Glass DS
The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Suspicion of 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
1. Contraindication for an ERCP per local standard of practice 2. Deemed contraindicated for POCS per local standard of practice 3. Prior biliary treatment of biliary anastomotic stricture 4. \< 18 years old 5. Documented life expectancy of less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Per-Oral Cholangioscopy on Patient Management | 12 Months | To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 12 Months | Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations. |
| Number of biliary re-interventions | 12 Months | Re-interventions may include but are not limited to repeat ERCP, repeat POCS, ultrasonography, stent exchanges, balloon dilations and liver biopsy. |
| Technical Success | 12 Months | Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology. |
| Relationship between endoscopic findings on POCS visualization | 12 Months | Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up. |
| Evaluation | 12 Months | Evaluation by surgeon of whether or not POCS impacted patient management post procedure. |
| Patient Management | 3 and 12 Months | Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate. |
Countries
Brazil, Netherlands, Spain, United States
Outcome results
None listed