Clinical Significance of Adherent Perinephric Fat in Patients Undergoing Partial Nephrectomy

NCT05887245 | Active Not Recruiting

• 1 other identifier: nr 21/2023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to gain a better understanding of the phenomenon of adherent perinephric fat (APF), which occurs in some patients undergoing partial nephrectomy (PN). This phenomenon, so-called "toxic fat", is a commonly recognized problem among urologists, but its significance has not yet been fully understood. The study aims to identify new clinical risk factors for APF occurrence and evaluate its impact on functional, perioperative, and oncological treatment outcomes. The study will be conducted on patients who are qualified for PN surgery. Prior to the surgical procedure, venous blood will be collected, which will be used for various measurements, such as blood morphology, kidney parameters, inflammation markers, liver function tests, glucose, and lipid profile. In addition, medical data will be collected concerning the patient's overall health, observed changes in the kidney, perioperative course, hospitalization, and histopathological characteristics of the tumor. After treatment, patients will be followed up for up to 60 months. The knowledge gained from this study can significantly assist in making decisions about surgical treatment and thus contribute to improving the treatment outcomes of patients with kidney tumors.

Conditions

Renal Cell Carcinoma; Kidney Neoplasm; Urologic Neoplasms; Urogenital Neoplasms; Kidney Diseases

Keywords

Partial Nephrectomy; Adherent Perinephric Fat

Outcome Measures

Primary Outcomes (1)

• Evaluation of clinical risk factors for the occurrence of adherent perinephric fat in patients undergoing partial nephrectomy.

  The following variables will be evaluated: 1. Anthropometric (sex; age in years; weight in kilograms; height in centimeters; waist circumference in centimeters) and comorbidity data (assessed with Charlson Comorbidity Index, 0-24). 2. Laboratory test results (C-reactive protein in mg/l; total cholesterol in mg/dl; triglycerides in mg/dl; high density lipoprotein in mg/dl; low density lipoprotein in mg/dl; ferritin in ng/ml; fasting glucose in mg/dl; creatinine in mg/dl; glomerular filtration rate calculated with the Modification of Diet in Renal Disease equation in ml/min/1,73 m²; white blood cell in G/l; lymphocyte in G/l; monocyte in G/l; hemoglobin in g/dl; platelets in G/l; neutrophil in G/l). 3. Imaging data and tumor features (maximum tumor diameter in millimeters; perirenal fat thickness in millimeters; Mayo Adhesive Probability score, 0 - 5; RENAL Nephrometry Score, 4 - 12).

  Data gathered in the pre-operative period. Blood samples collected one day prior to surgery.

Secondary Outcomes (1)

• Evaluation of the impact of adherent perinephric fat on functional, perioperative, and oncological treatment outcomes.

  Data gathered in the post-operative period. Observation period 6,12, 24, and 60 months after treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a radiological diagnosis of kidney tumor referred for surgical treatment with partial nephrectomy will be eligible.

You may qualify if:

• Patients qualified for partial nephrectomy by open, laparoscopic, or robotic method
• Tumor stage cT1a-cT1b according to Tumour Node Metastasis classification
• Age ≥ 18 years
• Written consent to participate in the study

You may not qualify if:

• Patient does not give consent to participate in the study
• Patients with recurrent kidney cancer, or who have undergone other surgeries within the kidney
• Lack of preoperative imaging available for assessment
• Missing medical documentation that prevents data analysis

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

European Health Centre, Second Department of Urology, Centre of Postgraduate Medical Education

Otwock, 05-400, Poland

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Sławomir Poletajew, Prof.

  Second Department of Urology, Centre of Postgraduate Medical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 2, 2023
• Study Start: April 17, 2023
• Primary Completion: April 17, 2025
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 27, 2025

Record last verified: 2024-11

Locations

PL (1)