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

Liver Graft Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04841278
• Other study ID #: 5170383
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Graft Dysfunction

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to final diagnosis	Time from first diagnostic test to final diagnosis	Up to 30 days