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Renal Artery Pseudoaneurysm After PCNL

Risk Factors, Clinical Features and Outcomes of Management for Renal Artery Pseudoaneurysm After PCNL: A Multicenter Retrospective Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07724912
Enrollment
50
Registered
2026-07-24
Start date
2026-09-09
Completion date
2027-05-29
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artery Pseudoaneurysm After PCNL

Keywords

Renal artery pseudoaneurysm, percutaneous nephrolithotomy, PCNL, retrospective multicenter study, risk factors, incidence, endovascular embolization

Brief summary

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

PROCEDUREEmbolization 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 the anatomical features and operator preference, microcoils (Guglielmi detachable coils or fibered coils), liquid embolic agents (Onyx, glutaraldehyde-acrylic copolymer), or a combination thereof are used. Completion angiography is performed to confirm complete occlusion of the pseudoaneurysm and preservation of blood flow in the unaffected renal artery branches. After removal of the introducer sheath, compression of the puncture site is applied for hemostasis.

Sponsors

Botkin Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frame
The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically)1 month
the proportion of patients with pseudoaneurysm who have the risk factors identified by the study.1 month

Secondary

MeasureTime frame
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).1 year
Volume of blood loss requiring transfusi1year

Contacts

CONTACTNikita Astakhov
botkinhospital@zdrav.mos.ru+7 (968) 490-46-72
STUDY_CHAIRVigen Malkhasyan, Doctor of Medical Sciences

Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Department of Healthcare; 2 Russian University of Medicine of the Ministry of Health of Russia

STUDY_DIRECTORDmitry Pushkar, Academician of the RAS

Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Department of Healthcare; 2 Russian University of Medicine of the Ministry of Health of Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026