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

Primary Purpose

Renal Cell Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic partial nephrectomy
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

renal cell carcinoma stages T1

renal cell carcinoma stages T2a

Arm Description

laparoscopic partial nephrectomy in renal cell carcinoma stage T1

laparoscopic partial nephrectomy in renal cell carcinoma stage T2a

Outcomes

Primary Outcome Measures

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.
Post-operative complications.
complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system
Local recurrence.
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine
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

Secondary Outcome Measures

Full Information

First Posted
August 3, 2022
Last Updated
August 3, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05486871
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2022 (Anticipated)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
renal cell carcinoma stages T1
Arm Type
Active Comparator
Arm Description
laparoscopic partial nephrectomy in renal cell carcinoma stage T1
Arm Title
renal cell carcinoma stages T2a
Arm Type
Active Comparator
Arm Description
laparoscopic partial nephrectomy in renal cell carcinoma stage T2a
Intervention Type
Procedure
Intervention Name(s)
laparoscopic partial nephrectomy
Intervention 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.
Primary Outcome Measure Information:
Title
Renal function.
Description
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.
Time Frame
3month
Title
Post-operative complications.
Description
complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system
Time Frame
3 month
Title
Local recurrence.
Description
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine
Time Frame
3 month
Title
Distant metastases.
Description
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
Time Frame
3 month

10. Eligibility

Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Attia, assisstent lecturer
Phone
01000962381
Email
ahmed.attia@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed s Saleem, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30100160
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.
Results Reference
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PubMed Identifier
31411969
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.
Results Reference
background
PubMed Identifier
29169703
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.
Results Reference
background
PubMed Identifier
30243799
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.
Results Reference
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Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.

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