Back to resultsPercutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor
Primary Purpose
Renal Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Renal biopsy
Cryoablation
Partial nephrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Renal Tumor focused on measuring Cryoablation, Renal cancer, Partial nephrectomy
Eligibility Criteria
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.
Sites / Locations
- Institute for Urology and Reproductive Health, Sechenov University.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cryoablation group
Partial nephrectomy group
Arm Description
Patients with T1b renal tumor and ECOQ>20
Patients with T1b renal tumor
Outcomes
Primary Outcome Measures
Local recurrence
Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Secondary Outcome Measures
Metastatic progression
Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
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
Renal function
Renal function will be evaluated with eGFR
Rate of adverse events
Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system
Blood loss
Pre- and postoperative Hb level
Length of hospital stay
Number of days spent in hospital
Pain score
Pain score will be assessed using visual analogue scale
Full Information
NCT ID
NCT04506671
First Posted
August 6, 2020
Last Updated
July 21, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04506671
Brief Title
Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
May 22, 2025 (Anticipated)
Study Completion Date
June 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Tumor
Keywords
Cryoablation, Renal cancer, Partial nephrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation group
Arm Type
Experimental
Arm Description
Patients with T1b renal tumor and ECOQ>20
Arm Title
Partial nephrectomy group
Arm Type
Active Comparator
Arm Description
Patients with T1b renal tumor
Intervention Type
Procedure
Intervention Name(s)
Renal biopsy
Intervention Description
Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
Intervention Type
Procedure
Intervention Name(s)
Partial nephrectomy
Intervention Description
Partial nephrectomy will be performed on the basis of the center and according to the current protocols
Primary Outcome Measure Information:
Title
Local recurrence
Description
Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Metastatic progression
Description
Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Time Frame
5 years
Title
Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)
Description
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
Time Frame
5 years
Title
Renal function
Description
Renal function will be evaluated with eGFR
Time Frame
5 years
Title
Rate of adverse events
Description
Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system
Time Frame
3 months
Title
Blood loss
Description
Pre- and postoperative Hb level
Time Frame
12 months
Title
Length of hospital stay
Description
Number of days spent in hospital
Time Frame
1 month
Title
Pain score
Description
Pain score will be assessed using visual analogue scale
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute for Urology and Reproductive Health, Sechenov University.
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, M.D., Ph.D
Phone
+7 9670897154
Email
enikeev-dv@1msmu.ru
First Name & Middle Initial & Last Name & Degree
Mark Taratkin, MD
Phone
+7 9670897154
Email
marktaratkin@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor
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