Utility of Combined EUS and ERCP Procedures in the Evaluation of Liver Graft Dysfunction

Study Overview
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Brief Summary
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The purpose of this investigator-initiated study is to determine whether a single-step session that combines endoscopic ultrasound (which may further include liver biopsy and needle-guided cholangiography) with endoscopic cholangiopancreatography (ERCP) can facilitate in the management of liver graft dysfunction. All patients will undergo the same procedural protocol.

Detailed Description
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Liver graft dysfunction can arise from many disease processes, which include biliary obstruction, rejection, infection and ischemia. Battery of tests, and at times empiric therapy, is necessary to obtain final diagnosis. This results in waste of time and medical resources that can lead to delay in care, which may ultimately translate to increase morbidity and mortality, as well as increase in cost. In this protocol, the investigators propose utilization of interventional endoscopy for the diagnosis and treatment of liver graft dysfunction. Use of endoscopic ultrasound (EUS) with possible liver biopsy and cholangiography, and endoscopic retrograde cholangiopancreatography in one session may facilitate diagnosis and treatment. All patients enrolled in this protocol will undergo the same procedural protocol. The quality of care metrics in these patients (such as length of stay, cost, mortality, etc), will be compared to that of historical controls.

Official Title
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Utility of Combined EUS and ERCP Procedures in the Evaluation of Liver Graft Dysfunction

Conditions
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Liver Graft Dysfunction

Intervention / Treatment
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* Device: EUS/ERCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All hospitalized patients with liver graft dysfunction Exclusion Criteria: Thrombocytopenia (platelets <50.000/mL) until corrected Coagulopathy (international normalized ratio (INR) >1.5) until corrrected Use of thrombolytic or anti-platelet agents within 5-7 days of the procedure. Any with known bleeding diathesis will be excluded. (e.g. disseminated intravascular coagulation (DIC), von-Willebrand disease, hemophilia). Those who had recent prior liver biopsy or EUS/ERCP will be excluded. Those with active bacteremia will be excluded, at least until treated. For this initial study, those with altered GI tract anatomy (e.g. those with hepaticojejunostomy or gastro-jejunostomy) will be excluded

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single prospective arm with historical controls as comparator
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS/ERCP<br>Patients with liver graft dysfunction enrolled sequentially for proposed protocol: EUS with possible interventions and possible ERCP | Device: EUS/ERCP<br>* EUS with possible interventions, including liver biopsy and/or cholangiography, and possible ERCP. No new experimental procedures are proposed, only new protocol for diagnosis and treatment of liver graft dysfunction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to final diagnosis | Time from first diagnostic test to final diagnosis | Up to 30 days |