Clinical trial NCT05486871: Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.
Official title: Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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

Primary outcomes:
measure: Renal function.
timeFrame: 3month
measure: Post-operative complications.
timeFrame: 3 month
measure: Local recurrence.
timeFrame: 3 month
measure: Distant metastases.
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018 Nov;103:356-387. doi: 10.1016/j.ejca.2018.07.005. Epub 2018 Aug 9.
citation: Vilaseca A, Guglielmetti G, Vertosick EA, Sjoberg DD, Grasso A, Benfante NE, Nguyen DP, Corradi RB, Coleman J, Russo P, Vickers AJ, Touijer KA. Value of Partial Nephrectomy for Renal Cortical Tumors of cT2 or Greater Stage: A Risk-benefit Analysis of Renal Function Preservation Versus Increased Postoperative Morbidity. Eur Urol Oncol. 2020 Jun;3(3):365-371. doi: 10.1016/j.euo.2019.04.003. Epub 2019 Apr 30.
citation: Munoz-Rodriguez J, Prera A, Dominguez A, de Verdonces L, Rosado MA, Martos R, Prats J. Laparoscopic partial nephrectomy: Comparative study of the transperitoneal pathway and the retroperitoneal pathway. Actas Urol Esp (Engl Ed). 2018 May;42(4):273-279. doi: 10.1016/j.acuro.2017.09.008. Epub 2017 Nov 21. English, Spanish.
citation: Capitanio U, Bensalah K, Bex A, Boorjian SA, Bray F, Coleman J, Gore JL, Sun M, Wood C, Russo P. Epidemiology of Renal Cell Carcinoma. Eur Urol. 2019 Jan;75(1):74-84. doi: 10.1016/j.eururo.2018.08.036. Epub 2018 Sep 19.