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

NCT ID: NCT04841278

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2022-12-01

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.

Conditions

Liver Graft Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EUS/ERCP

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

Group Type: EXPERIMENTAL

EUS/ERCP

Intervention Type: DEVICE

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.

Interventions

EUS/ERCP

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander W Jahng, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Other Identifiers

5170383

Identifier Type: -

Identifier Source: org_study_id