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

Sohag University

Status: Not yet enrolling

Conditions: Renal Cell Carcinoma

Treatments: Procedure: laparoscopic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05486871

Soh-Med-22-07-20

Details and patient eligibility

About

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 .

Enrollment: 30 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

renal cell carcinoma stages T1

Active Comparator group

Description:

laparoscopic partial nephrectomy in renal cell carcinoma stage T1

Treatment:

Procedure: laparoscopic partial nephrectomy

renal cell carcinoma stages T2a

Active Comparator group

Description:

laparoscopic partial nephrectomy in renal cell carcinoma stage T2a

Treatment:

Procedure: laparoscopic partial nephrectomy