A Prospective Observational Study of Foam Sclerotherapy .

NCT04111692 | Recruiting

• 1 other identifier: 17-006399
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

hepatic cyst; Kidney Cyst; Autosomal Polycystic Liver Disease; Autosomal Polycystic Kidney Disease

Outcome Measures

Primary Outcomes (4)

• Change in Pain Inventory

  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

  Baseline, 1 month, 6 month, 12 month

• Change in Self Assessed Quality of life

  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

  Baseline, 1 month, 6 month, 12 month

• Change in health related quality of life

  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

  Baseline, 1 month, 6 month, 12 month

• Change in Polycystic Liver Disease Quality of Life

  Measured using the self assessed Polycystic Liver Disease Questionnaire, using a scale that ranges from never/not at all to always/a lot

  Baseline, 1 month, 6 month, 12 month

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years
• Clinical diagnosis of ADPKD or ADPLD
• large, non-exophytic liver or kidney cyst
• Compressive symptoms from dominant cyst

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Marie Hogan, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassie Howe, CRC

CONTACT

507-266-1230; howe.cassie@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: October 1, 2019
• Study Start: November 6, 2017
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)