A Prospective Observational Study of Foam Sclerotherapy

Minnesota, United States

Overview
An observational prospective study to determine the impact of foam sclerotherapy of large, dominant kidney/liver cysts on quality of life outcomes and kidney/liver cyst volumes at up to 12 months of follow-up in patients with autosomal dominant polycystic kidney disease (ADPKD) and autosomal dominant polycystic liver disease (ADPLD).
Existing percutaneous treatments for cyst burden in ADPKD and ADPLD include cyst aspiration with or without sclerotherapy. Although frequently effective in the short-term, recurrence rates and the need for repeat procedures are high after these procedures (5, 6). Extrarenal disease (primarily liver disease) is the most important aspect of disease burden to ADPKD patients (7), and there are few effective treatments.

Foam sclerotherapy (FS) with 3% Sodium Tetradecyl Sulfate (STS) a sclerosing agent. (Sotradecol®; Mylan, Galway, Ireland) is approved by the FDA for the management of varicose veins. While increasing cyst burden significantly compromises quality of life, the impact of FS on patient-reported outcomes has not been evaluated. We aim to report our experience with a new therapeutic advance – FS for the treatment of liver and kidney cysts at Mayo Clinic – and to determine the impact of this procedure on patient-reported quality of life measures and changes in organ volumes.
Eligibility Criteria

  • Age ≥ 18 years
  • Clinical diagnosis of ADPKD or ADPLD
  • 1-3 large, non-exophytic liver or kidney cyst
  • Compressive symptoms from dominant cyst
  • Is not currently pregnant

Additional inclusion/exclusion criteria may apply

Locations
Mayo Clinic
Rochester, MN 55905

For additional information please contact:
Justin Patri, MS, CRC 507-293-3732, patri.justin@mayo.edu
Kathleen Leistikow, CRC 507-266-1316, leistikow.kathleen@mayo.edu