Clinical trial NCT04933604: LPN in Patients With High-complex Renal Tumors
Official title: Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cancer
Renal Neoplasm
Renal Cell Carcinoma
Surgery
Oncology
Kidney Ischemia
Kidney Injury
Urologic Neoplasms
Urologic Cancer
Kidney Neoplasms
Keywords: Laparoscopy
nephrometry score
partial nephrectomy
propensity score matching
radical nephrectomy
Lead sponsor: Samsun Liv Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2021-06-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Operation time
timeFrame: at the end of the surgery
measure: Blood loss
timeFrame: at the end of the surgery
measure: warm ischemia time
timeFrame: at the and of the surgery
measure: Postoperative complication
timeFrame: up to 3 months postoperatively
measure: functional outcomes
timeFrame: 1 year after the surgery
measure: surigcal margin status
timeFrame: postoperative follow-up, through study completion, an average of 1 year
measure: CKD stage upgrading
timeFrame: postoperative follow-up, through study completion, an average of 1 year
measure: Oncological outomes
timeFrame: postoperative follow-up, through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University, Department of Urology
Study officials:
affiliation: Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalı
name: Ender Ozden, Prof.
role: STUDY_DIRECTOR
affiliation: Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
name: Saban Sarıkaya, Prof.
role: STUDY_CHAIR
affiliation: Liv Hospital Samsun, Department of Urology
name: Mehmet Mercimek, MD, FEBU
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
name: Yakup Bostancı, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsun Gazi State Hospital, Departmen of Urology, Samsun, Turkey
name: Murat Gulsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.
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: 10.1016/j.eururo.2016.08.060. Epub 2016 Sep 7.
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.