Neoplasms

Symptoms and General Pathology

All Conditions

Cysts

Pathological Conditions, Anatomical

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Cefazolin

Antibiotics, Antitubercular

During this study all subjects undergo aspiration sclerotherapy and receive antibiotic prophylaxis with a single dose of cefazolin (intravenous infusion 1000mg) following standard care.

In order to secure patient safety and allow accurate measurement of cefazolin concentrations, an additional peripheral intravenous cannula (IVC) will be placed to allow blood withdrawal at three timepoints.

Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).

Peripheral intravenous cannula (IVC)

cefazolin

Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea. Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection, or following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive therapies. Evidence that antibiotics are able to reach adequate intracystic concentration is however lacking. To prevent procedure-related cyst infection in patients receiving aspiration sclerotherapy, cefazolin prophylaxis is given as standard of care. In this study we want to assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid concentrations of cefazolin. We hypothesize that cefazolin is able to penetrate hepatic cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of developing cyst infection following aspiration sclerotherapy.

Penetration of Cefazolin Into Hepatic Cysts

An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.

Radboud University Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Digestive System Diseases

Musculoskeletal Diseases

Nervous System Diseases

Rare Diseases

Kidney Diseases

Polycystic Kidney Diseases

Polycystic Kidney, Autosomal Dominant

Liver Diseases

Arthrogryposis

Gastrointestinal Diseases

Joint Diseases

Muscular Diseases

Congenital Abnormalities

Musculoskeletal Abnormalities

Kidney Diseases, Cystic

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Abnormalities, Multiple

Ciliopathies

Genetic Diseases, Inborn

Autosomal Dominant Multiple Pterygium Syndrome

Polycystic Liver Disease

Arthrogryposis Multiplex Congenita

Hematinics

Liver Extracts

Cassie Howe, CRC

Marie C Hogan, MD, PhD

Marie C. Hogan, M.D., Ph.D.

Marie Hogan, MD, PhD

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).

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.

A Prospective Observational Study of Foam Sclerotherapy .

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.

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

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

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

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

Mayo Clinic

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Penetration of Cefazolin Into Hepatic Cysts	NCT02368015	Hepatic Cyst	Peripheral intr... cefazolin	18 Years -	Radboud University Medical Center
A Prospective Observational Study of Foam Sclerotherapy .	NCT04111692	Autosomal Domin... Renal Cyst Autosomal Domin... Hepatic Cyst		18 Years - 100 Years	Mayo Clinic
A Prospective Observational Study of Foam Sclerotherapy .	NCT04111692	Autosomal Domin... Renal Cyst Autosomal Domin... Hepatic Cyst		18 Years - 100 Years	Mayo Clinic

Spots Global Cancer Trial Database for hepatic cyst

Every month we try and update this database with for hepatic cyst cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.