Renal TumorsNCT06954571
Imaging-Guided Classification for Endophytic Renal Tumors: PN Strategies & Outcomes
An observational study of Renal Tumors, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumors
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Patients without clinicopathologic, functional or prognosis data；
- Patients with unilateral multiple renal tumors , solitary kidney , or comorbid severe medical conditions；
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
About this study
Official title: 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
Read more
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
Read the detailed description
- 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 .
- Conditions
- Renal Tumors
- Keywords
- Renal Tumors
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: From enrollment to the end of 4 weeks of treatment
Secondary outcomes (17)
age
Patient's age at diagnosis
Measured: From enrollment to the end of 4 weeks of treatment
Gender
Sex of the patient, categorized as male, female.
Measured: From enrollment to the end of 4 weeks of treatment
Tumor side
Split into left and right side.
Measured: From enrollment to the end of 4 weeks of treatment
BMI
Body Mass Index.The formula is: BMI = weight ÷ height squared (weight in kilograms; height in meters)
Measured: From enrollment to the end of 4 weeks of treatment
Smoking history
"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
Measured: From enrollment to the end of 4 weeks of treatment
Alcohol use
"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.
Measured: From enrollment to the end of 4 weeks of treatment
Hypertension
"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
Measured: From enrollment to the end of 4 weeks of treatment
Diabetes
"0" means current or previous diabetes, '1' means no diabetes. Used to assess for a history of diabetes. To observe the effect on disease
Measured: From enrollment to the end of 4 weeks of treatment
ECOG performance status
0 Fully normal mobility, with no difference in mobility from that before the onset of the disease.
- Able to walk freely and engage in light physical activities, including general housework or office work, but unable to engage in heavier physical activities.
- 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.
- Can only partially take care of oneself, and spends more than half of the day in bed or in a wheelchair.
- Bedridden, unable to take care of themselves.
- Death Higher scores mean worse.
Measured: From enrollment to the end of 4 weeks of treatment
Charlson comorbidity index
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.
Measured: From enrollment to the end of 4 weeks of treatment
ASA score
- Physical health, good development and nutrition, normal function of organs. Perioperative mortality rate 0.06%-0.08%;
- Mild coexisting diseases other than surgical diseases, with sound functional compensation. Perioperative mortality rate 0.27%-0.40%;
- Severe coexisting conditions with limited physical activity, but still able to cope with daily activities. Perioperative mortality rate 1.82%-4.30%;
- Severe coexisting conditions with loss of ability to perform daily activities and frequent life threatening situations. Perioperative mortality rate 7.80%-23.0%;
- Dying patients who have difficulty sustaining life for 24 hours regardless of surgery. Perioperative mortality rate 9.40%-50.7%;
- Confirmed brain death with organs intended for organ transplantation.
Measured: From enrollment to the end of 4 weeks of treatment
P.A.D.U.A. score
The scores are 0, 1, 2, 3 and 4, ranging from "none" to "very serious", respectively.
Measured: From enrollment to the end of 4 weeks of treatment
R.E.N.A.L. score
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.
Measured: From enrollment to the end of 4 weeks of treatment
operative time
The time it takes the doctor to make the cut and the time it takes to close the incision.
Measured: From enrollment to the end of 4 weeks of treatment
estimated blood loss
By intraoperative blood loss, we actually mean loss of circulating blood volume
Measured: From enrollment to the end of 4 weeks of treatment
warm ischemia time
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.
Measured: From enrollment to the end of 4 weeks of treatment
Postoperative length of hospital stay
Length of hospitalization of patients after surgery
Measured: From enrollment to the end of 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jan 2018
- Primary completion30 Nov 2024
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954571
- Sponsor's protocol ID
- KY2025K002
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Mar;33(3):2791-2801. doi: 10.1245/s10434-025-18756-x. Epub 2025 Nov 22.
PubMed 41273672
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Imaging-Guided Classification System for Completely Endophytic Renal Tumors: Strategies for Optimal Partial Nephrectomy and Clinical Outcome Comparison
- ClinicalTrials.gov ID
- NCT06954571
- Acronym / sponsor ID
- KY2025K002
- Conditions
- Renal Tumors
- Keywords
- Renal Tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients without clinicopathologic, functional or prognosis data；
- Patients with unilateral multiple renal tumors , solitary kidney , or comorbid severe medical conditions；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
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.
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
17 secondary outcomes
age
Time frame: From enrollment to the end of 4 weeks of treatment
Gender
Time frame: From enrollment to the end of 4 weeks of treatment
Tumor side
Time frame: From enrollment to the end of 4 weeks of treatment
BMI
Time frame: From enrollment to the end of 4 weeks of treatment
Smoking history
Time frame: From enrollment to the end of 4 weeks of treatment
Alcohol use
Time frame: From enrollment to the end of 4 weeks of treatment
Hypertension
Time frame: From enrollment to the end of 4 weeks of treatment
Diabetes
Time frame: 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
Charlson comorbidity index
Time frame: From enrollment to the end of 4 weeks of treatment
ASA score
Time frame: 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
R.E.N.A.L. score
Time frame: From enrollment to the end of 4 weeks of treatment
operative time
Time frame: 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
warm ischemia time
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 41273672Wang 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. 2026 Mar;33(3):2791-2801. doi: 10.1245/s10434-025-18756-x. Epub 2025 Nov 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Tumors, run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical technique (time frame: From enrollment to the end of 4 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06954571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.