Clinical trial NCT06954571: Imaging-Guided Classification for Endophytic Renal Tumors: PN Strategies & Outcomes
Official title: A Novel Imaging-Guided Classification System for Completely Endophytic Renal Tumors: Strategies for Optimal Partial Nephrectomy and Clinical Outcome Comparison
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Tumors
Keywords: Renal Tumors
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who completed partial resection of completely endogenous renal cancer from January 2018 to November 2024 at the Second Hospital of Tianjin Medical University

Brief summary: Study Title:

Imaging-Guided Classification \& Surgical Outcomes in Endophytic Renal Tumors

Study Goal:

This observational study investigates whether an imaging-guided classification system improves partial nephrectomy (PN) outcomes for completely endophytic renal cell carcinoma (RCC).

Main Question:

Does preoperative imaging classification reduce complications (e.g., ischemia time, urinary leakage) in PN for endophytic RCC compared to traditional methods?

Methods:

Patients undergoing PN for endophytic RCC will be grouped based on preoperative imaging classification. Surgical outcomes (complications, renal function) will be tracked for 5 years and compared to non-classified PN cases.

Significance:

Aims to optimize PN planning, minimize risks, and improve long-term renal preservation in complex RCC cases

Detailed description: I. Background of the study Completely endogenous renal cell carcinoma (RCC) is challenging to perform partial nephrectomy (PN) due to the extensive contact area between normal renal parenchyma and RCC and the inability to accurately determine its location from the renal surface.Considering the anatomical complexity and the high risk of complications associated with PN, urologists had favored radical nephrectomy (RN) for completely endophytic RCC to mitigate complications .Advances in robotic-assisted laparoscopic surgery and the use of intraoperative ultrasound have led some clinicians to report prognostic and perioperative outcomes similar to those of RN treatment using PN for these complex endogenous RCCs .Although these studies suggest that PN is an available treatment option for fully endogenous RCC, PN treatment of fully endogenous RCC is usually associated with higher intraoperative and perioperative complications, including longer thermal ischemia time (WIT), higher rates of urinary leakage, and higher rates of positive surgical margins, when compared with PN treatment of non-endogenous RCC .Therefore, performing accurate preoperative planning is essential to help clinicians perform PN for fully endogenous RCC and to minimize associated complications.

In surgery with preservation of renal units, precise preoperative assessment and personalized surgical strategies are crucial for the preservation of postoperative renal function, reduction of complications, and improvement of long-term survival of patients .Therefore, the development of an imaging-based classification system to optimize surgical techniques for completely endophytic tumors is of great clinical importance.

The core objective of this study was to establish a scientific classification system for completely endophytic renal tumors through an imaging-guided preoperative classification method, to explore individualized surgical strategies for preserving renal units, and to analyze their performance in terms of postoperative clinical outcomes to provide new ideas and guidance for clinical practice .

Eligibility criteria: Inclusion Criteria:

1. Patients who completed partial resection of completely endogenous renal cancer from January 2018 to November 2024 at the Second Hospital of Tianjin Medical University；
2. Older than 18 years.

Exclusion Criteria:

1. Patients without clinicopathologic, functional or prognosis data；
2. Patients with unilateral multiple renal tumors , solitary kidney , or comorbid severe medical conditions；

Primary outcomes:
measure: Surgical technique
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Trifecta achievement
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Tumour subtype on histology
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: tumor size
timeFrame: From enrollment to the end of 4 weeks of treatment
Secondary outcomes:
measure: age
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Gender
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Tumor side
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: BMI
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Smoking history
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Alcohol use
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Hypertension
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Diabetes
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: ECOG performance status
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Charlson comorbidity index
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: ASA score
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: P.A.D.U.A. score
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: R.E.N.A.L. score
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: operative time
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: estimated blood loss
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: warm ischemia time
timeFrame: From enrollment to the end of 4 weeks of treatment
measure: Postoperative length of hospital stay
timeFrame: From enrollment to the end of 8 weeks of treatment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
Study officials:
References: