LPN in Patients With High-complex Renal Tumors

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Procedure: laparoscopic partial nephrectomy
* Procedure: Laparoscopic radical nephrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LPN group<br>39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy | Procedure: laparoscopic partial nephrectomy<br>* Nephron sparing minimally invasive surgery<br>|
| LRN group<br>39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy | Procedure: Laparoscopic radical nephrectomy<br>* Completely removal of kidney by using laparoscopic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | time from onset to complete of surgery | at the end of the surgery | 
| Blood loss | amount of bleeding during surgery (mL) | at the end of the surgery | 
| 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 | 
| Postoperative complication | abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up | up to 3 months postoperatively | 
| 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 | 
| surigcal margin status | presence or absence of tumors at the surgical margin | postoperative follow-up, through study completion, an average of 1 year | 
| 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 | 
| Oncological outomes | Presence or absence of local and/or distal tumor recurrence | postoperative follow-up, through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, nephrometry score, partial nephrectomy, propensity score matching, radical nephrectomy