Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Dec 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches for treating Bosniak III renal cysts, which are fluid-filled sacs in the kidney that may have a risk of being cancerous. The trial aims to compare "active surveillance," where patients are monitored over time, against immediate surgery to remove the cyst. Researchers want to see if it is safe and effective to just keep an eye on these cysts instead of automatically performing surgery, as many cysts might actually be benign (non-cancerous) and don’t require immediate treatment.

To be eligible for the trial, participants need to be at least 50 years old and have a single Bosniak III cyst that is between 10 to 70 millimeters in size. They should be healthy enough to undergo either surgery or monitoring and must understand the information provided in the study. Participants will be randomly assigned to either the active surveillance group, where they will be followed for 10 years with regular check-ups, or the surgery group. This study could potentially help reduce unnecessary surgeries for patients with these types of cysts, leading to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A sporadic single CM of Bosniak 3 according to the Bosniak Classification v.2019 is diagnosed with CT or MRI
• • Maximal diameter of CM 10-70 mm
• • Age ≥50 years
• • ECOG performance status \<2
• • Life expectancy ≥5 years
• • Patient is fit to undergo surgery and AS.
• • Patient understands a national language or English
• • Signed informed consent
• Exclusion Criteria:
• • Genetic syndromes associated with RCC
• • Previously or simultaneously diagnosed and pathologically verified RCC
• • Previously or simultaneously radiographically identified solid mass or CM of Bosniak 3/4 with diameter ≥10mm
• • The target CM of Bosniak 3 has progressed in sequential imaging from Bosniak 1-2F
• • Presence of radiographic findings which are suspect for nodal or distant metastatic disease
• • Symptomatic CM
• • Kidney insufficiency (GFR\<55 ml/min/1,73m2)
• • Patients who have contraindications for both CT and MRI imaging. . Anatomically solitary kidney