Partial NephrectomyNCT06916910
Analysis of Predictive Factors for Urinary Leakage After Partial Nephrectomy for Renal Hilum Tumors
An observational study of Partial Nephrectomy and Renal Hilum Tumors, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
In this study, we plan to explore the risk factors closely related to the occurrence of urinary leakage after partial nephrectomy for renal hilum tumors through retrospective analysis of multicenter clinical data, thereby providing clinical guidance value for the prevention of postoperative urinary leakage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Partial Nephrectomy, Renal Hilum Tumors, Urinary Leakage
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2024to 18 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing partial nephrectomy for renal hilum tumors
Who may be able to join
- CT or MRI angiography indicates a renal hilum tumor, and the patient has undergone partial nephrectomy;
- The Eastern Cooperative Oncology Group (ECOG) performance status score is between 0 and 1, and the age is between 18 and 75 years old;
- The clinicopathological data are complete;
- There is no infection, autoimmune disease, hematological disease, or other malignancies.
Who cannot join
- The patient has surgical contraindications;
- There are congenital malformations of the urinary system, obstructive nephropathy, or other diseases that seriously affect the function of the urinary system before surgery;
- The patient has received relevant treatments that may affect the results of this study, such as radiotherapy in the kidney area, a history of kidney surgery, etc.;
- There are tumors in both kidneys.
Trial locations and contacts
1 site in 1 country.
China1 site
first hospital affiliated of Fujian medical university
Fuzhou, Fujian, 350005
About this study
Official title: Analysis of Predictive Factors for Urinary Leakage After Partial Nephrectomy for Renal Hilum Tumors: A Multicenter Retrospective Clinical Study
In this study, we plan to explore the risk factors closely related to the occurrence of urinary leakage after partial nephrectomy for renal hilum tumors through retrospective analysis of multicenter clinical data, thereby providing clinical guidance value for the prevention of postoperative urinary leakage.
- Conditions
- Partial Nephrectomy, Renal Hilum Tumors, Urinary Leakage
- Keywords
- urinary leakage, partial nephrectomy, renal hilum tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative urinary leakage
Postoperative urinary leakage is defined as the postoperative perirenal drainage volume being greater than 50 ml for 7 consecutive days and the creatinine level of the drainage fluid being similar to that of urine(μmol/L), or postoperative urinary leakage being suspected by imaging examination.
Measured: the postoperative perirenal drainage volume being greater than 50 ml for 7 consecutive days and the creatinine level of the drainage fluid being similar to that of urine(μmol/L), or postoperative urinary leakage being suspected by imaging examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start18 Sep 2024
- Primary completion18 Sep 2025 (estimated)
- Study completion18 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial NephrectomyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Xiamen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916910
- Sponsor's protocol ID
- MRCTA,ECFAH OfFMU[2024]905
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Predictive Factors for Urinary Leakage After Partial Nephrectomy for Renal Hilum Tumors: A Multicenter Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT06916910
- Acronym / sponsor ID
- MRCTA,ECFAH OfFMU[2024]905
- Conditions
- Partial Nephrectomy, Renal Hilum Tumors, Urinary Leakage
- Keywords
- urinary leakage, partial nephrectomy, renal hilum tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Xiamen University
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 18 Sep 2025 (estimated)
- Study completion
- 18 Sep 2025 (estimated)
- First posted
- 8 Apr 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.
In this study, we plan to explore the risk factors closely related to the occurrence of urinary leakage after partial nephrectomy for renal hilum tumors through retrospective analysis of multicenter clinical data, thereby providing clinical guidance value for the prevention of postoperative urinary leakage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing partial nephrectomy for renal hilum tumors
Key inclusion criteria (4 listed)
- CT or MRI angiography indicates a renal hilum tumor, and the patient has undergone partial nephrectomy;
- The Eastern Cooperative Oncology Group (ECOG) performance status score is between 0 and 1, and the age is between 18 and 75 years old;
- The clinicopathological data are complete;
- There is no infection, autoimmune disease, hematological disease, or other malignancies.
Key exclusion criteria (4 listed)
- The patient has surgical contraindications;
- There are congenital malformations of the urinary system, obstructive nephropathy, or other diseases that seriously affect the function of the urinary system before surgery;
- The patient has received relevant treatments that may affect the results of this study, such as radiotherapy in the kidney area, a history of kidney surgery, etc.;
- There are tumors in both kidneys.
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
Postoperative urinary leakage
Time frame: the postoperative perirenal drainage volume being greater than 50 ml for 7 consecutive days and the creatinine level of the drainage fluid being similar to that of urine(μmol/L), or postoperative urinary leakage being suspected by imaging examination.
Postoperative urinary leakage is defined as the postoperative perirenal drainage volume being greater than 50 ml for 7 consecutive days and the creatinine level of the drainage fluid being similar to that of urine(μmol/L), or postoperative urinary leakage being suspected by imaging examination.
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 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 Partial Nephrectomy and Renal Hilum Tumors, run by First Affiliated Hospital of Fujian Medical University 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 4 inclusion and 4 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 8 Apr 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?
Postoperative urinary leakage (time frame: the postoperative perirenal drainage volume being greater than 50 ml for 7 consecutive days and the creatinine level of the drainage fluid being similar to that of urine(μmol/L), or postoperative urinary leakage being suspected by imaging examination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.