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

Not Applicable

Withdrawn

• Conditions: Liver Graft Dysfunction
• Interventions: Device: EUS/ERCP

• Registration Number: NCT04841278
• Lead Sponsor: Loma Linda University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-10-28
• Study Start: 2017-12-01
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Posted: 2021-04-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS/ERCP	EUS/ERCP	Patients with liver graft dysfunction enrolled sequentially for proposed protocol: EUS with possible interventions and possible ERCP

Primary Outcome Measures

Name	Time	Method
Time to final diagnosis	Up to 30 days	Time from first diagnostic test to final diagnosis