Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

Renal Tumor Clinical Trial

Official title:

A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506671
• Other study ID #: CA_vs_PN
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2020
• Est. completion date: June 22, 2025

Study information

• Verified date: July 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: June 22, 2025
• Est. primary completion date: May 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

•CT-confirmed renal mass > 4 to 7 cm (T1b)

Exclusion Criteria:

• Multiple renal tumors;

• Recurrence of renal tumor;

• Intolerance to iodine-containing contrast agents;

• Pregnancy;

• Patients with Bosniak 4 cysts

• Presence of other oncological diseases;

• Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system

• Absence of malignant pathology based on prior biopsy.

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Tumor

Intervention

Procedure:
• Renal biopsy
Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols
• Cryoablation
Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
• Partial nephrectomy
Partial nephrectomy will be performed on the basis of the center and according to the current protocols

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence	Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment	5 years
Secondary	Metastatic progression	Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment	5 years
Secondary	Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)	Quality of life will be assessed using scales EORTC QLQ C-30, ranging from 1 to 100, where higher score indicating a better Quality of Life	5 years
Secondary	Renal function	Renal function will be evaluated with eGFR	5 years
Secondary	Rate of adverse events	Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system	3 months
Secondary	Blood loss	Pre- and postoperative Hb level	12 months
Secondary	Length of hospital stay	Number of days spent in hospital	1 month
Secondary	Pain score	Pain score will be assessed using visual analogue scale	5 years