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

NCT04841278 | Withdrawn FDA Device

• 1 other identifier: 5170383
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Graft Dysfunction

Outcome Measures

Primary Outcomes (1)

• Time to final diagnosis

  Time from first diagnostic test to final diagnosis

  Up to 30 days

Study Arms (1)

EUS/ERCP

EXPERIMENTAL

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

Device: EUS/ERCP

Interventions

EUS/ERCP 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.

EUS/ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All hospitalized patients with liver graft dysfunction

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Officials

• Alexander W Jahng, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single prospective arm with historical controls as comparator

Study Record Dates

• First Submitted: October 28, 2017
• First Posted: April 12, 2021
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share