Skip to main content
OpenTrials
Completed

NCT Number: NCT04933604

LPN in Patients With High-complex Renal Tumors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Injury Kidney Ischemia Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oncology Renal Cell Carcinoma Renal Neoplasm Surgery Urogenital Diseases Urogenital Neoplasms Urologic Cancer Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayıs University, Department of Urology

Samsun, 55020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic partial nephrectomy

Procedure

Nephron sparing minimally invasive surgery

Laparoscopic Radical Nephrectomy

Procedure

Completely removal of kidney by using laparoscopic surgery

Primary outcomes

  1. Operation time

    Time frame: at the end of the surgery

    time from onset to complete of surgery

  2. Blood loss

    Time frame: at the end of the surgery

    amount of bleeding during surgery (mL)

  3. warm ischemia time

    Time frame: at the and of the surgery

    The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy

  4. Postoperative complication

    Time frame: up to 3 months postoperatively

    abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up

  5. functional outcomes

    Time frame: 1 year after the surgery

    serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)

  6. surigcal margin status

    Time frame: postoperative follow-up, through study completion, an average of 1 year

    presence or absence of tumors at the surgical margin

  7. CKD stage upgrading

    Time frame: postoperative follow-up, through study completion, an average of 1 year

    evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages

  8. Oncological outomes

    Time frame: postoperative follow-up, through study completion, an average of 1 year

    Presence or absence of local and/or distal tumor recurrence

Sponsors and collaborators

Lead sponsor

Samsun Liv Hospital

Other

Collaborators

  • Ondokuz Mayıs University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.