Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.

Study Overview
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Brief Summary
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RCC represents around 3% of all cancers, with the highest incidence occurring in Western countries . Within the several RCC risk factors identified, smoking, obesity, and hypertension are most strongly associated with RCC . The EUA guidelines recommend PN for patients with T1 tumors, as PN preserved kidney function better after surgery, thereby potentially lowering the risk of development of cardiovascular disorders as well as improving overall survival(OS) for PN compared to RN, there is very limited evidence on the optimal surgical treatment for patients with larger renal masses (T2) . Currently, the upper limit of PN indications remains undefined and is determined by an individual surgeon's expertise and preference. The degree of variability in the choice between PN and RN for a given tumor increases with tumor size. Surgeons committed to nephron-sparing are likely to expand the indications of PN, while those concerned with increased morbidity and doubtful of the clinical relevance of a moderate decrease in renal function are likely to perform RN, regardless of tumor size .

Official Title
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Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: laparoscopic partial nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with localized RCC ≤ 10 cm in preoperative contrast enhanced imaging(T1 and T2a). Exclusion Criteria: Patients who had other tumors benign tumors clinically unfit metastatic RCC patients with Clinical T2b or higher tumors, tumors with maximum diameter > 10cm
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: renal cell carcinoma stages T1<br>laparoscopic partial nephrectomy in renal cell carcinoma stage T1 | Procedure: laparoscopic partial nephrectomy<br>* This is a prospective non- randomized controlled study of patients with RCC Who will be referred to urology department, Sohag university hospital. Our comparative study contained two groups according to tumor stage at preoperative contrast study: Group [A] : 15 patients with T1 RCC (≤ 7 cm). Group [B] : 15 patients with T2a RCC (≤ 10 cm). the patients will be subjected to laparoscopic partial nephrectomy then will be followed up for two years for oncological and functional outcomes.<br>|
| Active Comparator: renal cell carcinoma stages T2a<br>laparoscopic partial nephrectomy in renal cell carcinoma stage T2a | Procedure: laparoscopic partial nephrectomy<br>* This is a prospective non- randomized controlled study of patients with RCC Who will be referred to urology department, Sohag university hospital. Our comparative study contained two groups according to tumor stage at preoperative contrast study: Group [A] : 15 patients with T1 RCC (≤ 7 cm). Group [B] : 15 patients with T2a RCC (≤ 10 cm). the patients will be subjected to laparoscopic partial nephrectomy then will be followed up for two years for oncological and functional outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function. | Patients' pre and postoperative eGFR values were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation, with the postoperative eGFR based on the creatinine measurement taken closest to 1 yr after surgery (between 9 and 15 month postoperatively). The eGFR downgrade was defined as preoperative eGFR 60 ml/min/1.73 m2 and postoperative eGFR <60 ml/min/1.73 m2 at 1 yr after surgery. | 3month | 
| Post-operative complications. | complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system | 3 month | 
| Local recurrence. | radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine | 3 month | 
| Distant metastases. | radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine and bone scan incase of bone pain or pathological fractures CT BRAIN incase of manifestation of increased intracranial tension | 3 month |