Actively Recruiting
A Prospective Observational Study of Foam Sclerotherapy for the Treatment of Symptomatic Kidney or Liver Cysts in Patients With Autosomal Dominant Polycystic Kidney and Liver Disease.
Led by Mayo Clinic · Updated on 2026-01-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of foam sclerotherapy on large kidney or liver cysts in patients with autosomal dominant polycystic kidney disease (ADPKD) and autosomal dominant polycystic liver disease (ADPLD). These cysts can cause discomfort and reduce quality of life, and this observational study aims to understand how foam sclerotherapy influences cyst size and patient-reported quality of life over a 12-month period. The study leverages a patient-reported outcome tool approved by the FDA to measure symptom burden in polycystic liver disease. The study observes patients who undergo foam sclerotherapy using 3% Sodium Tetradecyl Sulfate (Sotradecol®), a treatment currently approved for varicose veins. Patients have 1 to 3 large, non-exophytic cysts causing compressive symptoms, and researchers monitor changes in cyst volume and symptoms. The procedure targets cysts in the liver or kidney, and follow-up visits occur up to 12 months after treatment to assess changes. Participants will be assessed at baseline and then at 1 month, 6 months, and 12 months after treatment. Researchers collect data on pain, quality of life, and health-related quality of life using specialized questionnaires validated for this condition. Organ volumes are measured through imaging to track cyst changes. Patients must comply with follow-up visits, provide informed consent, and the study excludes those who are pregnant or have too many or too small cysts. Overall participation can last over a year to measure the treatment's impact.
CONDITIONS
Brief Title
A Prospective Observational Study of Foam Sclerotherapy .
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD) or autosomal dominant polycystic liver disease (ADPLD)
- Presence of 1 to 3 large, non-exophytic liver or kidney cysts
- Experiencing compressive symptoms from the dominant cyst
You will not qualify if you...
- Age under 18 years
- No diagnosis of ADPKD or ADPLD
- Largest cyst smaller than 4 cm in all three dimensions or cyst volume less than 400 cc
- More than 3 large, non-exophytic liver or kidney cysts measuring 4 cm or larger in all three dimensions (cyst volume 400 cc or greater)
- Unwillingness to comply with study follow-up protocol for approximately 12 months after foam sclerotherapy
- Lacking capacity to provide informed consent for foam sclerotherapy of liver or kidney cysts
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 months
Participants who undergo routine foam sclerotherapy treatment for liver or kidney cysts are observed to assess changes in symptoms and organ volumes over time.
Visits at baseline, 1 month, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Cassie Howe, CRC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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