A Prospective Observational Study of Foam Sclerotherapy .
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|ClinicalTrials.gov Identifier: NCT04111692|
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : February 20, 2020
|Condition or disease|
|Autosomal Dominant Polycystic Kidney Renal Cyst Autosomal Dominant Polycystic Liver Disease Hepatic Cyst|
Cyst burden is an important determinant of outcomes in both autosomal dominant polycystic kidney disease (ADPKD) (1, 2) and autosomal dominant polycystic liver disease (ADPLD) (3, 4). Furthermore, mass symptoms (from liver and kidney volume) greatly impact upon quality of life in patients with severe disease. Cyst volume increases exponentially with age and results in the development of end-stage renal disease and hypertension, compromised quality of life due to compressive symptoms, and predisposes patients to cyst complications such as infection, hemorrhage, rupture, and torsion. 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. In collaboration with the Center for Science of Healthcare delivery, we have developed a patient-reported outcome tool for polycystic liver disease capable of detecting symptom burden in individuals with polycystic liver disease that has been approved by the FDA as a patient-reported outcomes tool in research. Furthermore measurement of liver and kidney volumes can be performed in the Polycystic Kidney Disease Imaging Research Core that monitors organ volumes before and after interventions. At this time, patients are interested in procedures that will alleviate and palliate their mass symptoms but desire preliminary information on the procedural efficacy. 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||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.|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||December 10, 2020|
|Estimated Study Completion Date :||December 10, 2020|
- Change in Pain Inventory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111692
|Contact: Kathleen R Leistikow, ACRCemail@example.com|
|Contact: Troy G Ofstie, RN CRCfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Marie C Hogan, MD, PhD 507-266-1963 email@example.com|
|Principal Investigator: Marie C. Hogan, M.D., Ph.D.|