This is a 5-year prospective, longitudinal, observational study of all patients
undergoing TIPS placement. The study will accrue patients until the goal of 1,000
subjects is reached. Subjects will be followed prospectively for up to a total of 5
years. Patients will be clinically managed by their local physicians per standard of care
and no specific treatments or interventions will be dictated by their enrollment in this
study. Patients will be consented to enroll in the study prior to TIPS placement or
within 14 days after TIPS placement (such as in the event of emergent TIPS) and their
pertinent clinical information will be then collected. Subjects may be consented
electronically using REDCap eConsent or docusign. Pre-TIPS participants will be asked to
complete a short set of questionnaires and one verbal assessment both pre-TIPS and
post-TIPS during regularly scheduled visits with their treating hepatologist. Blood and
rectal samples will be collected as optional procedures, and participation in these
procedures will not affect participation in the study. Patients will be asked to consent
to three different 5mL blood samples (total 15mL) at the time of TIPS from the
peripheral, central, and portal venous circulation. A 5 ml peripheral sample will also be
collected at months 1, 6, and 12 post-TIPS. The peripheral blood samples will occur
either prior to TIPS (time 0) in the IR suite or at months 1, 6 and 12 post-TIPS. The
central and portal venous blood sample will occur during the TIPS procedure in the IR
suite. The total blood volume collection throughout the study will be 30mL. The rectal
swab will be performed by the IR/ anesthesia team prior to the TIPS procedure in the IR
suite. During the prospective post-TIPS period all medical records will be reviewed
including clinical notes, laboratory values, radiographic results and medication changes
and this data will be inputted into the database. Participants will be asked to also
complete the same questionnaires regarding their quality of life and patient reported
outcomes at prespecified timepoints post-TIPS, at a minimum 3 months and 12 months
post-TIPS placement and then yearly thereafter. The hepatic encephalopathy assessments
and AUDIT-C questionnaire will be conducted at month 1, 3, 6,12 and then yearly
thereafter as part of their usual post-TIPS care.
