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

Loma Linda University (LLU)

Status

Withdrawn

Conditions

Liver Graft Dysfunction

Treatments

Device: EUS/ERCP

Study type

Interventional

Funder types

Other

Identifiers

NCT04841278

5170383

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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