NCT05486871

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

August 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 3, 2022

Last Update Submit

August 3, 2022

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

  • Renal function.

    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.

    3month

  • Post-operative complications.

    complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system

    3 month

  • Local recurrence.

    radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine

    3 month

  • Distant metastases.

    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

    3 month

Study Arms (2)

renal cell carcinoma stages T1

ACTIVE COMPARATOR

laparoscopic partial nephrectomy in renal cell carcinoma stage T1

Procedure: laparoscopic partial nephrectomy

renal cell carcinoma stages T2a

ACTIVE COMPARATOR

laparoscopic partial nephrectomy in renal cell carcinoma stage T2a

Procedure: laparoscopic partial nephrectomy

Interventions

laparoscopic partial nephrectomyPROCEDURE

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 T1renal cell carcinoma stages T2a

Eligibility Criteria

Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who had other tumors
  • benign tumors
  • clinically unfit
  • metastatic RCC
  • patients with Clinical T2b or higher tumors,
  • tumors with maximum diameter \> 10cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 30100160BACKGROUND

  • 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.

    PMID: 31411969BACKGROUND

  • 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.

    PMID: 29169703BACKGROUND

  • 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.

    PMID: 30243799BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Ahmed M Attia, assisstent lecturer

CONTACT

01000962381ahmed.attia@med.sohag.edu.eg

Mohamed s Saleem, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistent lecturer at urology department

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 4, 2022

Study Start

August 20, 2022

Primary Completion

August 20, 2024

Study Completion

August 20, 2024

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

EG(1)