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临床试验/NCT06954571
NCT06954571进行中(未招募)不适用

A Novel Imaging-Guided Classification System for Completely Endophytic Renal Tumors: Strategies for Optimal Partial Nephrectomy and Clinical Outcome Comparison

Tianjin Medical University Second Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
190
试验地点
1
主要终点
Surgical technique

研究概览

简要总结

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

详细描述

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 .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

Surgical technique

时间窗: From enrollment to the end of 4 weeks of treatment

Surgical options for completely endogenous renal cancer include laparoscopic, open, and robotic. The impact on the patient is assessed according to the different surgical modalities.

Trifecta achievement

时间窗: From enrollment to the end of 4 weeks of treatment

In renal cancer surgery (particularly partial nephrectomy), the Trifecta achievement consists of: * Negative surgical margins (no residual tumor) * No perioperative complications (e.g., hemorrhage, urinary leakage) * Preservation of renal function (minimal decline in eGFR)

Tumour subtype on histology

时间窗: From enrollment to the end of 4 weeks of treatment

The tumor subtypes of renal cancer studied in this study included clear cell carcinoma, papillary carcinoma, and smoky cell carcinoma.

tumor size

时间窗: From enrollment to the end of 4 weeks of treatment

It was used to assess the size of the tumor, and in this study, due to the endogenous nature of the tumor, the tumors were generally small, less than 5 cm

次要结局

  • estimated blood loss(From enrollment to the end of 4 weeks of treatment)
  • Postoperative length of hospital stay(From enrollment to the end of 8 weeks of treatment)
  • Tumor side(From enrollment to the end of 4 weeks of treatment)
  • BMI(From enrollment to the end of 4 weeks of treatment)
  • Gender(From enrollment to the end of 4 weeks of treatment)
  • age(From enrollment to the end of 4 weeks of treatment)
  • Smoking history(From enrollment to the end of 4 weeks of treatment)
  • Alcohol use(From enrollment to the end of 4 weeks of treatment)
  • Hypertension(From enrollment to the end of 4 weeks of treatment)
  • Diabetes(From enrollment to the end of 4 weeks of treatment)
  • ECOG performance status(From enrollment to the end of 4 weeks of treatment)
  • Charlson comorbidity index(From enrollment to the end of 4 weeks of treatment)
  • ASA score(From enrollment to the end of 4 weeks of treatment)
  • P.A.D.U.A. score(From enrollment to the end of 4 weeks of treatment)
  • R.E.N.A.L. score(From enrollment to the end of 4 weeks of treatment)
  • operative time(From enrollment to the end of 4 weeks of treatment)
  • warm ischemia time(From enrollment to the end of 4 weeks of treatment)

研究者

发起方
Tianjin Medical University Second Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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