A Study of the Development and Validation of an Ascites-Specific Patient Reported Outcomes Questionnaire

Overview

About this study

The purpose of this study is to develop and validate a brief patient reported outcomes questionaire that is responsive to ascites-related symptoms in 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

Ascites Patients
- Age ≥ 18 years
- Experiencing symptomatic ascites based on
  - Cirrhosis defined by histological, clinical or radiological criteria
  - Abdominal malignancy or peritoneal carcinomatosis
Control Group
- Cirrhosis defined by histological, clinical or radiological criteria
- No signs of ascites based on physical examination or ultrasound

Exclusion Criteria

Impaired cognitive function as deemed by the investigators such as hepatic encephalopathy > Grade 2 following the West Haven Criteria [14] or as a result of brain metastasis
Unable to speak or read English fluently
Admitted to the hospital at time of paracentesis

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 Patrick Kamath, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Kamath, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials