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.

NCT04111692 RECRUITING

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).

Details

Lead sponsor	Mayo Clinic
Status	RECRUITING
Enrolment	100
Start date	2017-11-06
Completion	2027-11

Conditions

• Autosomal Dominant Polycystic Kidney
• Renal Cyst
• Autosomal Dominant Polycystic Liver Disease
• Hepatic Cyst

Primary outcomes

• Change in Pain Inventory — Baseline, 1 month, 6 month, 12 month
  Measured using self assessed brief pain inventory (short form) questionnaire, using a scale of 0 is no pain and 10 is pain as bad as you can imagine
• Change in Self Assessed Quality of life — Baseline, 1 month, 6 month, 12 month
  Measured using the linear analogue self assessed questionnaire, using a scale of 0 is as bad as it can be and 10 is as good as it can be
• Change in health related quality of life — Baseline, 1 month, 6 month, 12 month
  Measured using the self assessed Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), using a scale that ranges from yes and no or all of the time to none of the time
• Change in Polycystic Liver Disease Quality of Life — Baseline, 1 month, 6 month, 12 month
  Measured using the self assessed Polycystic Liver Disease Questionnaire, using a scale that ranges from never/not at all to always/a lot

Countries

United States