Imaging-Guided Classification for Endophytic Renal Tumors: PN Strategies & Outcomes

NCT06954571 | Active Not Recruiting DMC

• 1 other identifier: KY2025K002
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Tumors

Keywords

Renal Tumors

Outcome Measures

Primary Outcomes (4)

• Surgical technique

  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.

  From enrollment to the end of 4 weeks of treatment

• Trifecta achievement

  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)

  From enrollment to the end of 4 weeks of treatment

• Tumour subtype on histology

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

  From enrollment to the end of 4 weeks of treatment

• tumor size

  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

  From enrollment to the end of 4 weeks of treatment

Secondary Outcomes (17)

• age

  From enrollment to the end of 4 weeks of treatment

• Gender

  From enrollment to the end of 4 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

• Smoking history

  From enrollment to the end of 4 weeks of treatment

Study Arms (3)

Type1

The tumor is entirely confined within the renal parenchyma, positioned transversely between the ventral and dorsal aspects of the kidney and sagittally within the relatively avascular zone between the upper and lower polar lines, without invading renal pelvis structures.

Type2

The tumor is located on the ventral aspect of the kidney, adjacent to the anterior wall of the calyx, without involvement of the collecting system . IIb: The tumor is situated on the dorsal aspect of the renal pelvis, closely adjacent to the posterior calyceal wall, without invading the collecting system

Type3

The tumor occupies the renal hilum region, involves the renal lip or renal sinus, and is closely associated with renal arteries, veins, and the collecting system.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

Related Publications (1)

• Wang K, Zhang J, Zhou W, Liu Y, Yao Z, Yao J, Liu Y, Zhang J, Liu K, Li G. A Novel Imaging-Guided Classification System for Completely Endophytic Renal Tumors: Strategies for Optimal Partial Nephrectomy and Clinical Outcome Comparison. Ann Surg Oncol. 2025 Nov 22. doi: 10.1245/s10434-025-18756-x. Online ahead of print.

  PMID: 41273672 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: January 1, 2018
• Primary Completion: November 30, 2024
• Study Completion: August 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-04

Locations

CN (1)