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

Not Applicable

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: laparoscopic partial nephrectomy

• Registration Number: NCT05486871
• Lead Sponsor: Sohag University

Brief Summary

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Study Start: 2022-08-20
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Patients with localized RCC ≤ 10 cm in preoperative contrast enhanced imaging(T1 and T2a).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
renal cell carcinoma stages T1	laparoscopic partial nephrectomy	laparoscopic partial nephrectomy in renal cell carcinoma stage T1
renal cell carcinoma stages T2a	laparoscopic partial nephrectomy	laparoscopic partial nephrectomy in renal cell carcinoma stage T2a

Primary Outcome Measures

Name	Time	Method
Renal function.	3month	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.
Post-operative complications.	3 month	complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system
Local recurrence.	3 month	radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine
Distant metastases.	3 month	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

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt