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Trial Title:
Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.
NCT ID:
NCT05486871
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopic partial nephrectomy
Description:
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.
Arm group label:
renal cell carcinoma stages T1
Arm group label:
renal cell carcinoma stages T2a
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 .
Criteria for eligibility:
Criteria:
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
Gender:
Male
Gender based:
Yes
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sohag University Hospital
Address:
City:
Sohag
Country:
Egypt
Contact:
Last name:
Osama R Elshrif, professor
Start date:
August 20, 2022
Completion date:
August 20, 2024
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05486871
