Renal Artery Pseudoaneurysm After PCNL

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Artery Pseudoaneurysm After PCNL
• Intervention / Treatment: Procedure: Embolization of a renal artery branch pseudoaneurysm

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Nikita Astakhov; Phone Number: +7 (968) 490-46-72; Email: botkinhospital@zdrav.mos.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with renal artery pseudoaneurysm after PCNL

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with renal artery pseudoaneurysm after PCNL; Patients who underwent percutaneous nephrolithotomy and subsequent development of renal artery pseudoaneurysm, verified by CT angiography, where the complication could either present with bleeding or have an asymptomatic course

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time 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 transfusi	1year

Collaborators and Investigators

• Sponsor: Botkin Hospital
• Investigators: Study Chair: Vigen 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 Director: Dmitry 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

Study record dates

Study Major Dates

• Study Start (Estimated): September 9, 2026
• Primary Completion (Estimated): May 7, 2027
• Study Completion (Estimated): May 29, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Renal artery pseudoaneurysm, percutaneous nephrolithotomy, PCNL, retrospective multicenter study, risk factors, incidence, endovascular embolization
• Other Study ID Numbers: Urology20261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No