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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation group | Experimental | Patients with T1b renal tumor and ECOQ>20 |
|
| Partial nephrectomy group | Active Comparator | Patients with T1b renal tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal biopsy | Procedure | Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) |
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Inclusion Criteria:
•CT-confirmed renal mass > 4 to 7 cm (T1b)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Urology and Reproductive Health, Sechenov University. | Recruiting | Moscow | 119991 | Russia |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Cryoablation | Procedure | Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols |
|
| Partial nephrectomy | Procedure | Partial nephrectomy will be performed on the basis of the center and according to the current protocols |
|
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 |
| Renal function | Renal function will be evaluated with eGFR | 5 years |
| Rate of adverse events | Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system | 3 months |
| Blood loss | Pre- and postoperative Hb level | 12 months |
| Length of hospital stay | Number of days spent in hospital | 1 month |
| Pain score | Pain score will be assessed using visual analogue scale | 5 years |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |