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A Prospective Observational Study of Foam Sclerotherapy .

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111692
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Marie Hogan, Mayo Clinic

Brief Summary:
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).

Condition or disease
Autosomal Dominant Polycystic Kidney Renal Cyst Autosomal Dominant Polycystic Liver Disease Hepatic Cyst

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects with ADPKD or ADPLD and large, symptomatic kidney or liver cysts followed in Nephrology or Hepatology clinics at Mayo Clinic, or de novo referrals to Mayo Clinic, Rochester, MN will be invited to participate.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Kathleen R Leistikow, ACRC 507-266-1316 leistikow.kathleen@mayo.edu
Contact: Troy G Ofstie, RN CRC 507-255-1087 ofstie.troy@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Marie C Hogan, MD, PhD    507-266-1963    hogan.marie@mayo.edu   
Principal Investigator: Marie C. Hogan, M.D., Ph.D.         
Sponsors and Collaborators
Mayo Clinic

Additional Information:
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Responsible Party: Marie Hogan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04111692    
Other Study ID Numbers: 17-006399
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marie Hogan, Mayo Clinic:
hepatic cyst
Kidney Cyst
Autosomal Polycystic Liver Disease
Autosomal Polycystic Kidney Disease
Additional relevant MeSH terms:
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Cysts
Liver Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Digestive System Diseases
Neoplasms
Pathological Conditions, Anatomical
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn