Observing the effects of foam sclerotherapy on kidney and liver cysts
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.
This study is testing if foam sclerotherapy can help reduce the size of large kidney and liver cysts in people with polycystic kidney and liver diseases and improve their quality of life over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04111692 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of foam sclerotherapy on large kidney and liver cysts in patients with autosomal dominant polycystic kidney disease (ADPKD) and autosomal dominant polycystic liver disease (ADPLD). It will assess changes in cyst volumes and quality of life outcomes over a follow-up period of up to 12 months. The study will utilize a patient-reported outcome tool specifically designed for polycystic liver disease to gather relevant data. By focusing on patients with significant cyst burden, the study seeks to provide insights into the effectiveness of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of ADPKD or ADPLD and significant compressive symptoms from large cysts.
Not a fit: Patients with multiple large cysts or those whose largest cysts are below the specified size criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients suffering from large cysts associated with ADPKD and ADPLD.
How similar studies have performed: While foam sclerotherapy has been used for other conditions, this specific application for ADPKD and ADPLD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Clinical diagnosis of ADPKD or ADPLD * 1-3 large, non-exophytic liver or kidney cyst * Compressive symptoms from dominant cyst Exclusion Criteria: * Age \<18 years * Absence of ADPKD or ADPLD * Largest cyst \<4cm in all 3 dimensions or largest cyst volume \<400cc * \>3 large, non-exophytic liver or kidney cyst(s) ≥4cm in all 3 dimensions (cyst volume ≥400cc) * Unwilling to comply with study follow-up protocol to 12 ± 1months post-FS * Lacking capacity to provide informed consent to FS of liver or kidney cysts * Pregnancy
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Marie Hogan, MD, PhD — Mayo Clinic
- Study coordinator: Cassie Howe, CRC
- Email: howe.cassie@mayo.edu
- Phone: 507-266-1230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.