POCS in Liver Transplantation Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Per-Oral Cholangioscopy in Liver Transplantation Patients

Conditions
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Liver Transplant; Complications

Intervention / Treatment
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* Device: Spy Glass DS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver transplantation at least 1 month prior to POCS procedure Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms Prior cross sectional imaging (MRI and/or US and/or CT) Suspicion of anastomotic biliary stricture(s) Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging Willing and able to provide a written informed consent to participate in the study Willing and able to comply with study procedures and follow-up schedule Exclusion Criteria: Contraindication for an ERCP per local standard of practice Deemed contraindicated for POCS per local standard of practice Prior biliary treatment of biliary anastomotic stricture < 18 years old Documented life expectancy of less than 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERCP & Spy Glass DS<br>Patients with cadaveric donor or live donor liver transplantation referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct strictures. | Device: Spy Glass DS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Per-Oral Cholangioscopy on Patient Management | To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology. | 12 Months | 
| Serious Adverse Events | Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations. | 12 Months | 
| Number 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. | 12 Months | 
| Patient Management | Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate. | 3 and 12 Months | 
| Relationship between endoscopic findings on POCS visualization | Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up. | 12 Months | 
| Evaluation | Evaluation by surgeon of whether or not POCS impacted patient management post procedure. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Per-Oral Cholangioscopy, Liver Transplantation, Spy Glass