LPN in Patients With High-complex Renal Tumors

NCT04933604 | Completed

• 1 other identifier: OMU KAEK 11.07.2019/538
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

LPN group

39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy

Procedure: laparoscopic partial nephrectomy

LRN group

39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy

Procedure: Laparoscopic radical nephrectomy

Interventions

laparoscopic partial nephrectomy PROCEDURE

Nephron sparing minimally invasive surgery

LPN group

Laparoscopic radical nephrectomy PROCEDURE

Completely removal of kidney by using laparoscopic surgery

LRN group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsun Liv Hospital: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Ondokuz Mayıs University, Department of Urology

Samsun, 55020, Turkey (Türkiye)

Location

Related 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):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.

  PMID: 27988238 RESULT

• 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.

  PMID: 27614693 RESULT

• 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.

  PMID: 31677114 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell; Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ender Ozden, Prof.

  Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalı

  STUDY DIRECTOR

• Saban Sarıkaya, Prof.

  Ondokuz Mayıs University, Faculty of Medicine, Department of Urology

  STUDY CHAIR

• Mehmet Mercimek, MD, FEBU

  Liv Hospital Samsun, Department of Urology

  PRINCIPAL INVESTIGATOR

• Yakup Bostancı, Prof.

  Ondokuz Mayıs University, Faculty of Medicine, Department of Urology

  PRINCIPAL INVESTIGATOR

• Murat Gulsen, MD

  Samsun Gazi State Hospital, Departmen of Urology, Samsun, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 22, 2021
• Study Start: September 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: February 4, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

TU (1)