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

May 6, 2025 updated by: Tianjin Medical University Second Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • The Second Hospital Of Tianjin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical technique
Time Frame: 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.
From enrollment to the end of 4 weeks of treatment
Trifecta achievement
Time Frame: 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)
From enrollment to the end of 4 weeks of treatment
Tumour subtype on histology
Time Frame: 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.
From enrollment to the end of 4 weeks of treatment
tumor size
Time Frame: 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
From enrollment to the end of 4 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Smoking history
Time Frame: From enrollment to the end of 4 weeks of treatment
"0" means current or former smoker, '1' means no smoking. Used to assess whether or not one has smoked. To observe the effect on disease
From enrollment to the end of 4 weeks of treatment
Alcohol use
Time Frame: From enrollment to the end of 4 weeks of treatment
"0" indicates current or previous alcohol consumption and '1' indicates no alcohol consumption. Used to assess whether or not one has been drinking. To observe the effect on disease.
From enrollment to the end of 4 weeks of treatment
Hypertension
Time Frame: From enrollment to the end of 4 weeks of treatment
"0" means having or currently having high blood pressure and '1' means not having high blood pressure. It is used to assess whether or not a person has ever had a hypertensive disorder.To observe the effect on disease
From enrollment to the end of 4 weeks of treatment
Diabetes
Time Frame: From enrollment to the end of 4 weeks of treatment
"0" means current or previous diabetes, '1' means no diabetes. Used to assess for a history of diabetes. To observe the effect on disease
From enrollment to the end of 4 weeks of treatment
age
Time Frame: From enrollment to the end of 4 weeks of treatment
Patient's age at diagnosis
From enrollment to the end of 4 weeks of treatment
Gender
Time Frame: From enrollment to the end of 4 weeks of treatment
Sex of the patient, categorized as male, female.
From enrollment to the end of 4 weeks of treatment
Tumor side
Time Frame: From enrollment to the end of 4 weeks of treatment
Split into left and right side.
From enrollment to the end of 4 weeks of treatment
BMI
Time Frame: From enrollment to the end of 4 weeks of treatment
Body Mass Index.The formula is: BMI = weight ÷ height squared (weight in kilograms; height in meters)
From enrollment to the end of 4 weeks of treatment
ECOG performance status
Time Frame: From enrollment to the end of 4 weeks of treatment

0 Fully normal mobility, with no difference in mobility from that before the onset of the disease.

  1. Able to walk freely and engage in light physical activities, including general housework or office work, but unable to engage in heavier physical activities.
  2. Able to walk freely and take care of oneself, but with loss of working ability, and can get up and move around not less than half of the time during the day.
  3. Can only partially take care of oneself, and spends more than half of the day in bed or in a wheelchair.
  4. Bedridden, unable to take care of themselves.
  5. Death Higher scores mean worse.
From enrollment to the end of 4 weeks of treatment
Charlson comorbidity index
Time Frame: From enrollment to the end of 4 weeks of treatment

Score 0: Low risk. The patient has no specific co-morbidities included in the CCI score, indicating that the patient is relatively healthy and has a high survival rate.

Score 1-2: Moderate risk. Patients may have one or two milder co-morbidities, but overall risk is relatively low.

Score 3-4: Moderate to high risk. Patients may have a moderate burden of co-morbidities and may have reduced survival.

Score 5-6: High risk. Patients have a high burden of co-morbidities and may require closer monitoring and care.

Score 7 and above: Very high risk. The patient has a more severe burden of co-morbidities and may have significantly reduced survival and a higher risk of treatment.
From enrollment to the end of 4 weeks of treatment
ASA score
Time Frame: From enrollment to the end of 4 weeks of treatment
  1. Physical health, good development and nutrition, normal function of organs. Perioperative mortality rate 0.06%-0.08%;
  2. Mild coexisting diseases other than surgical diseases, with sound functional compensation. Perioperative mortality rate 0.27%-0.40%;
  3. Severe coexisting conditions with limited physical activity, but still able to cope with daily activities. Perioperative mortality rate 1.82%-4.30%;
  4. Severe coexisting conditions with loss of ability to perform daily activities and frequent life threatening situations. Perioperative mortality rate 7.80%-23.0%;
  5. Dying patients who have difficulty sustaining life for 24 hours regardless of surgery. Perioperative mortality rate 9.40%-50.7%;
  6. Confirmed brain death with organs intended for organ transplantation.
From enrollment to the end of 4 weeks of treatment
P.A.D.U.A. score
Time Frame: From enrollment to the end of 4 weeks of treatment
The scores are 0, 1, 2, 3 and 4, ranging from "none" to "very serious", respectively.
From enrollment to the end of 4 weeks of treatment
R.E.N.A.L. score
Time Frame: From enrollment to the end of 4 weeks of treatment

The R.E.N.A.L. scoring system is based on the anatomical features of renal tumors, including tumor size (R), convexity (E), relationship to the renal sinus and collecting system (N), ventral or dorsal renal location (A), location along the longitudinal axis of the kidney (L), and relationship to the renal hilum (h), and quantitatively evaluates each aspect based on the scores.

Higher scores mean worse.
From enrollment to the end of 4 weeks of treatment
operative time
Time Frame: From enrollment to the end of 4 weeks of treatment
The time it takes the doctor to make the cut and the time it takes to close the incision.
From enrollment to the end of 4 weeks of treatment
estimated blood loss
Time Frame: From enrollment to the end of 4 weeks of treatment
By intraoperative blood loss, we actually mean loss of circulating blood volume
From enrollment to the end of 4 weeks of treatment
warm ischemia time
Time Frame: From enrollment to the end of 4 weeks of treatment
The length of time between blocking the blood supply to the kidneys, the state of persistent ischemia at room temperature, and the restoration of the blood supply.
From enrollment to the end of 4 weeks of treatment
Postoperative length of hospital stay
Time Frame: From enrollment to the end of 8 weeks of treatment
Length of hospitalization of patients after surgery
From enrollment to the end of 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Second Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025K002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Tumors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings