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

NCT ID: NCT05486871

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-20
• Study Completion Date: 2024-08-20

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 .

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

renal cell carcinoma stages T1

laparoscopic partial nephrectomy in renal cell carcinoma stage T1

Group Type: ACTIVE_COMPARATOR

laparoscopic partial nephrectomy

Intervention Type: PROCEDURE

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.

renal cell carcinoma stages T2a

laparoscopic partial nephrectomy in renal cell carcinoma stage T2a

Group Type: ACTIVE_COMPARATOR

laparoscopic partial nephrectomy

Intervention Type: PROCEDURE

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.

Interventions

laparoscopic partial nephrectomy

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mahmoud Attia

assistent lecturer at urology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

Ahmed M Attia, assisstent lecturer

Role: CONTACT

ahmed.attia@med.sohag.edu.eg

01000962381

Mohamed s Saleem, professor

Role: CONTACT

Facility Contacts

Osama R Elshrif, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 30100160 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31411969 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29169703 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30243799 (View on PubMed)

Other Identifiers

Soh-Med-22-07-20

Identifier Type: -

Identifier Source: org_study_id