An interventional study of Delayed surgery and Immediate surgery in Cystic Renal Disease, Kidney Cancer and Surgery, sponsored by Helsinki University Central Hospital. Not yet recruiting. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
The incidence of renal cysts is rising due to increased abdominal imaging. Renal complicated cysts have been traditionally classified according to the Bosniak classification, which distinguishes cystic masses by specific features of walls and septa. The categories I and II are benign and class IIF most probably benign but needs a short radiological follow-up. Categories III and IV have been traditionally operated due to the increased risk of renal cell carcinoma. However, recently published studies show that approximately 50% of the operated Bosniak III cystic masses are benign, which means that half of the cases are overtreated by surgery. It has also been shown that surgical pathology of stable Bosniak IIF cysts is malignant in less than 1%, while the cysts, which are upgraded to higher Bosniak classes will show malignant surgical pathology in 85%. So far, there is lack of prospective data on active surveillance in Bosniak III cystic masses.
The aim of the study is to compare active surveillance and surgery in patients with Bosniak III renal cystic masses. Patients will be randomized in active surveillance or immediate surgical excision of a cystic mass. In the active surveillance group, patients are followed according to the study protocol for 10 years and treated with delayed surgery if the cystic mass upgrades into Bosniak IV/solid, becomes symptomatic or grows over a preclassified threshold. The primary objective is to compare surgical pathology between patients treated with immediate surgery versus delayed surgery.
According to recent retrospective data, active surveillance of Bosniak III cystic masses is reasonable and oncologically safe. Therefore a prospective randomized controlled trial is needed to get high level evidence to support a change in the treatment strategy. The study may significantly reduce unnecessary operations performed in patients with Bosniak III cystic masses.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 200 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Patients undergo excision of a renal mass by partial or radical nephrectomy and will be followed by UISS risk classification.
Procedure: Immediate surgery
Patients enter active surveillance protocol. Delayed surgery on active surveillance will be recommended if progression from Bosniak 3 to 4 or a solid mass is noted on imaging by radiologist
Procedure: Delayed surgery
Delayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance.
Partial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass
Malignancy rate in surgical pathology
Time frame: From date of randomization until the date of surgery, assessed up to 120 months
Cancer specific survival
Time frame: From date of randomization until the date of death due to renal cancer, assessed up to 120 months
Progression-free survival
Time frame: From date of randomization until the date of first documented progression, assessed up to 120 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 120 months
No study locations are listed for this record.
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital