International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
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|ClinicalTrials.gov Identifier: NCT05363657|
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : May 6, 2022
Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries' social background and performance of health system) are important to address the best personalized approach in patients with renal tumors.
In the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics.
To meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project.
The expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years).
|Condition or disease||Intervention/treatment|
|Kidney Cancer||Procedure: Partial Nephrectomy (PN) Procedure: Radical Nephrectomy (RN) Procedure: Ablation therapy (AT) Diagnostic Test: Active Surveillance (AS)|
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)|
|Actual Study Start Date :||January 10, 2022|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2028|
Renal tumor patiens
Patients with any renal tumor diagnosed with conventional imaging (computed tomography or magnetic resonance imaging) and undergoing to a clinical management in a hugh-volume center.
Procedure: Partial Nephrectomy (PN)
Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Procedure: Radical Nephrectomy (RN)
Surgical removal of the affected kidney. Adrenal removal can be performed according to surgeon choice and clinical characteristics of the renal tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Procedure: Ablation therapy (AT)
The procedure of tumor ablation performed with radiofrequency or cryoablation. The procedure can be performed either with a laparoscopic approach or percutaneous access.
Diagnostic Test: Active Surveillance (AS)
Active surveillance is defined as the initial management including the monitoring of renal tumor size by serial imaging with delayed treatment in case of progression.
- To test the effectiveness of partial nephrectomy for the treatment of localized renal tumors (T1-T2N0M0) with regards to recurrence-free survival and cardiovascular accidents and mortality in comparison to radical nephrectomy? [ Time Frame: Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years ]
The preoperative characteristics of the patients will be specifically evaluated to calculate any heterogeneity between the two groups. In detail, anthropometric and comorbidity features, previous abdominal surgery, blood chemistry values, blood pressure, smoking habit, preoperative life expectancy, and frailty grade will be assessed. Imaging features of the tumor will be considered, including the characteristics necessary for the calculation of the PADUA, R.E.N.A.L., and Contact-Surface-Area scores. Patients with a node-positive or metastatic disease diagnosed with conventional imaging (CT scan/MRI) will be excluded. Intra-operative and post-operative outcomes will be evaluated. Histopathological features of the tumor will be assessed.
Patients will be followed up with conventional imaging according to the International guidelines (ultrasound, CT, MRI). Serum creatinine, platelets and estimated glomerular function (eGFR), the onset of cardiovascular adverse events will be registered.
- To test the effectiveness of robotic approach in partial nephrectomy to increase the "Trifecta" rate after nephron-sparing surgery in patients with T1-T2N0M0 renal tumors. [ Time Frame: Assesment of the "Trifecta" outcome will be performed at 12 months from the surgical intervention. Time frame: 1 year. ]
"Trifecta" rate is defined as 1) Absence of intraoperative and postoperative surgical complications; 2) absence of positive surgical margins or recurrences on tumor resection site during a 5-year follow-up; 3) Absence of clinically significant renal function loss at one year after surgery. Renal function will be evaluated using the estimated glomerular filtration rate (eGFR) in ml/min/1.73 m^2 using the CKD-EPI Creatinine Equation (2021). A clinically significant loss will be considered if >25% from eGFR at baseline.
The "Trifecta" outcome will be evaluated one year from surgery.
- To evaluate the differential impact of patients' comorbidities, tumors' complexity, surgeons' experience, country-related socio-cultural factors and hospital financial resources on the selection of the type of clinical management. [ Time Frame: Assesment will be done at the time of registering the type of surgery/clinical managing adopted. Time frame: <1 week from patients accrual.. ]
The following variables will be evaluated:
- Anthropometric, pre-operative and comorbidity data (patient characteristics).
- Imaging data and pre-operative tumor features (tumor characteristics).
- Centre facilities (laparoscopic/robot assisted, interventional radiology) , volume centre (PN/RN ratio, availability of Multidisciplinary Tumor Board)
- Intra-operative and post-operative data (treatment characteristics).
- Histopathological analysis (tumor histopathological characteristics). The outcome will be considered as the type of clinical management selected: active surveillance (AS) vs ablative treatment (AT) vs partial nephrectomy (PN) vs radical nephrectomy (RN).
- To evaluate the impact of the antiaggregant and/or antiplatelet treatment at baseline and during partial nephrectomy on hemorrhagic complications. [ Time Frame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months ]
The eventual anticoagulant therapy (heparin, warfarin, enoxaparin, fondaparinux) and/or antiplatelet therapy (clopidogrel, ticagrelor, prasugrel, dipyridamole, dipyridamole/aspirin, ticlopidine, eptifibatide) use in patients at baseline and at time of surgery will be assessed.
Hemorrhagic complications (graded according to the "Clavien-Dindo classification") will be evaluated during surgery (intraoperative) and within 90 days (postoperative) with particular attention to the management of hemorrhage (patient monitoring, transfusion, selective embolization, re-intervention with/without kidney removal).
- To assess in patients with antiaggregant and/or antiplatelet treatment at baseline any potential change of this therapy at the time of treatment associated with the absence of hemorrhagic complications. [ Time Frame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months ]
The eventual anticoagulant therapy (heparin, warfarin, NAO, enoxaparin, fondaparinux) and/or antiplatelet therapy (clopidogrel, ticagrelor, prasugrel, dipyridamole, dipyridamole/aspirin, ticlopidine, eptifibatide) use in patients at baseline and at time of surgery will be assessed.
Change of treatment from baseline to time of surgery will be considered and specifically evaluated according to the underlying cardio- and/or peripheral- and/or cerebro-vascular diseases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363657
|Contact: Marco Carini, Prof.||055 794 email@example.com|
|Contact: Andrea Minervini, Prof.||055 794 firstname.lastname@example.org|
|Principal Investigator:||Andrea Minervini, Prof.||Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)|