Liver Ascites Patient Treatment Preferences of Implantable Devices
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-009292
- Scottsdale/Phoenix, Arizona: 22-009292
About this study
The puropose of this study is to utilize a discrete-choice experiment (DCE) survey to elicit benefit-risk preferences for interventional treatment attributes in patients with refractory or recurrent ascites due to liver cirrhosis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients aged 18 years or older
- Cirrhosis of liver defined by histological and/or clinical, endoscopic, laboratory, and radiological criteria.
- Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis.
- Not a candidate for (refused, contraindicated) TIPS or previously implanted TIPS is permanently obstructed or nonfunctioning.
- Life expectancy of at least 6 months.
- Capable of giving written informed consent and able to understand and complete the survey in English In addition, the clinics were asked to recruit a small number of patients who had received an implanted pump and would have satisfied the eligibility criteria above before receiving the implanted pump. The inclusion criteria for the online survey will be exactly as indicated for the pretest interviews, with the additions described as follows: Received paracentesis more than 1 time in the last 30 days, confirmed by physician and patient report.
- Stage 0 hepatic encephalopathy, confirmed by physician report.
- Ascites symptoms Stage 1, 2, or 3, confirmed by physician report.
- Has a life expectancy of at least 6 months, confirmed by physician report 6 Therapeutic paracentesis is defined as removal of at least 1.5 L of ascitic fluid by means of percutaneous drainage with therapeutic intent in patients with symptoms related to fluid accumulation or clear evidence of ascites accumulation (weight gain, abdominal circumference), excluding patients receiving a puncture for diagnostic purpose only. Patient Preference for an Implantable Device to Treat Liver Ascites: Final Protocol 35.
- At least half the sample will include patients who are not candidates for (refused, contraindicated) TIPS or in whom a previously implanted TIPS is permanently obstructed or nonfunctioning.
Exclusion Criteria:
- Patients who have been enrolled to participate in the clinical trial for the alfapump, including people who have been enrolled but have not been implanted with an alfapump or are no longer implanted.
Eligibility last updated 8/29/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jody Olson, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Hugo Vargas, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available