Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

NCT ID: NCT04506671

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2025-06-22

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryoablation group

Patients with T1b renal tumor and ECOQ\>20

Group Type EXPERIMENTAL

Renal biopsy

Intervention Type PROCEDURE

Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols

Cryoablation

Intervention Type PROCEDURE

Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols

Partial nephrectomy group

Patients with T1b renal tumor

Group Type ACTIVE_COMPARATOR

Partial nephrectomy

Intervention Type PROCEDURE

Partial nephrectomy will be performed on the basis of the center and according to the current protocols

Interventions

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Renal biopsy

Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols

Intervention Type PROCEDURE

Cryoablation

Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols

Intervention Type PROCEDURE

Partial nephrectomy

Partial nephrectomy will be performed on the basis of the center and according to the current protocols

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dmitry Enikeev, MD, PhD

Deputy Director for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Urology and Reproductive Health, Sechenov University.

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Dmitry Enikeev, M.D., Ph.D

Role: primary

+7 9670897154

Mark Taratkin, MD

Role: backup

+7 9670897154

Other Identifiers

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CA_vs_PN

Identifier Type: -

Identifier Source: org_study_id

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