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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERCP & Spy Glass DS | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spy Glass DS | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Cadaveric donor or live donor liver transplantation patients referred for ERCP in the setting of a clinical suspicion of post-liver transplant bile duct stricture(s).
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| Name | Affiliation | Role |
|---|---|---|
| Amrita Sethi, MD | Columbia University | Principal Investigator |
| Eduardo De Moura, MD | Hospital das Clinicas University of Sao Paulo | Principal Investigator |
| Adam Slivka, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Andres Cardenas, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Marco Bruno, MD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital CUMC | New York | New York | 10032 | United States | ||
| University of Pittsburgh Medical Center |
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Biopsies if needed at the discretion of the PI.
|
| 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 |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Hospital das Clinicas | São Paulo | 05403 | Brazil |
| Erasmus Medical Center | Rotterdam | 3015 | Netherlands |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |