LPN in Patients With High-complex Renal Tumors

Surgery Clinical Trial

Official title:

Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933604
• Other study ID #: OMU KAEK 11.07.2019/538
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: June 2021
• Source: Samsun Liv Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.

Description:

From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 4, 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with complete data
• Patients with single renal tumor on the effected side
• Patients who approved the written consent form

Exclusion Criteria:

• Patients who not approved the written consent form
• Patients with incomplete data
• Patients with low or mild complexity renal tumors

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Ischemia
• Kidney Injury
• Kidney Ischemia
• Kidney Neoplasms
• Neoplasms
• Oncology
• Renal Cancer
• Renal Cell Carcinoma
• Renal Neoplasm
• Surgery
• Urologic Cancer
• Urologic Neoplasms

Intervention

Procedure:
• laparoscopic partial nephrectomy
Nephron sparing minimally invasive surgery
• Laparoscopic radical nephrectomy
Completely removal of kidney by using laparoscopic surgery

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University, Department of Urology	Samsun

Sponsors (2)

Lead Sponsor	Collaborator
Samsun Liv Hospital	Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):6 — View Citation

Mir MC, Derweesh I, Porpiglia F, Zargar H, Mottrie A, Autorino R. Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies. Eur Urol. 2017 Apr;71(4):606-617. doi: 10. — View Citation

Yang F, Zhou Q, Xing N. Comparison of survival and renal function between partial and radical laparoscopic nephrectomy for T1b renal cell carcinoma. J Cancer Res Clin Oncol. 2020 Jan;146(1):261-272. doi: 10.1007/s00432-019-03058-z. Epub 2019 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	time from onset to complete of surgery	at the end of the surgery
Primary	Blood loss	amount of bleeding during surgery (mL)	at the end of the surgery
Primary	warm ischemia time	The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy	at the and of the surgery
Primary	Postoperative complication	abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up	up to 3 months postoperatively
Primary	functional outcomes	serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)	1 year after the surgery
Primary	surigcal margin status	presence or absence of tumors at the surgical margin	postoperative follow-up, through study completion, an average of 1 year
Primary	CKD stage upgrading	evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages	postoperative follow-up, through study completion, an average of 1 year
Primary	Oncological outomes	Presence or absence of local and/or distal tumor recurrence	postoperative follow-up, through study completion, an average of 1 year