Renal Artery Pseudoaneurysm After PCNL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Embolization of a renal artery branch pseudoaneurysm.
- Who it may be relevant to
- Registry conditions: Artery Pseudoaneurysm After PCNL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk Factors, Clinical Features and Outcomes of Management for Renal Artery Pseudoaneurysm After PCNL: A Multicenter Retrospective Study
Overview
In a multicenter retrospective study, to assess the incidence and risk factors of renal artery pseudoaneurysm after percutaneous nephrolithotomy, and to characterize the clinical presentation and treatment outcomes.
Detailed description
Pseudoaneurysm (PA) is a false lumen that arises from a defect in the layers of the arterial wall, around which a hematoma forms, and reactive fibrosis leads to the development of a saccular structure connected to the arterial lumen by a neck; renal arteriovenous fistula results from injury to the wall of the main or segmental renal arteries, and the injury may be traumatic (most commonly penetrating), iatrogenic, or sometimes secondary to an inflammatory or neoplastic process. The main iatrogenic causes include percutaneous nephrolithotomy (PCNL), percutaneous renal biopsy, percutaneous nephrostomy, and renal resection; diagnosis is primarily based on color Doppler ultrasound, contrast-enhanced computed tomographic angiography (CTA), or angiography, and treatment options depend on the site of injury, with endovascular embolization being the first-line therapy. The aim of this study is to identify, within a multicenter retrospective study, the incidence and risk factors for the development of renal artery pseudoaneurysm in patients following percutaneous nephrolithotomy, and to determine the clinical features and effectiveness of treatment methods. The objectives of the study are: to assess the incidence of this complication; to evaluate the clinical presentation and severity of the complication; to determine the nature and effectiveness of treatment methods; to assess treatment outcomes; to identify risk factors for the development of the complication; and to develop a risk assessment scale for pseudoaneurysm after PCNL based on the identified risk factors. The study type and design is a retrospective multicenter cohort study. Inclusion criteria are: age ≥18 years, patients who underwent PCNL, pseudoaneurysm confirmed by CTA or angiography, and a follow-up period of at least 30 days after the procedure. Exclusion criteria are: known pre-existing vascular anomalies or abnormalities in the kidney, and absence of key data required for analysis (incomplete medical records). Outcomes assessed include: development of renal artery branch pseudoaneurysm after PCNL; time to detection of PA after PCNL; development of bleeding from the pseudoaneurysm; effectiveness of conservative methods; effectiveness of endovascular intervention; and effectiveness of renal exploration and nephrectomy. Materials and methods: the study will analyze medical record data from patients who underwent PCNL and developed the complication of renal artery pseudoaneurysm; data will be provided by different centers that perform such procedures. Sample size calculation was performed accounting for clustering of data across centers: with an expected embolization rate of 80%, precision of ±10%, confidence level of 95%, intraclass correlation coefficient of 0.03, and an average cluster size of 8 patients, the design effect was 1.21, and the adjusted sample size is 75 patients with pseudoaneurysm.
Interventions
- Procedure Embolization of a renal artery branch pseudoaneurysm
Endovascular embolization of a renal artery branch pseudoaneurysm is performed under local anesthesia and sedation. Following Seldinger puncture of the common femoral artery, an introducer sheath is placed. Diagnostic renal angiography is performed to localize the pseudoaneurysm and assess the vascular anatomy. Selective catheterization of the affected branch is achieved using a microcatheter. An embolic material is delivered into the pseudoaneurysm lumen or into the feeding vessel. Depending on
Primary outcome measures
- The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically) [Time frame: 1 month]
- the proportion of patients with pseudoaneurysm who have the risk factors identified by the study. [Time frame: 1 month]
Secondary outcome measures (2)
- Frequency of hemodynamic instability requiring the use of inotropic agents (unit of measurement: yes/no; measurement instrument: monitoring of blood pressure and heart rate, protocol of inotropic administration). [Time frame: 1 year]
- Volume of blood loss requiring transfusi [Time frame: 1year]
Eligibility criteria
Inclusion criteria
Age ≥18 years
Underwent percutaneous nephrolithotomy (PCNL)
Renal artery pseudoaneurysm confirmed by CT angiography
Follow-up ≥30 days post-procedure
Exclusion criteria
Known pre-existing renal vascular anomalies or abnormalities
Incomplete medical records (missing key data for analysis)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07724912 · Urology20261