- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07724912
Renal Artery Pseudoaneurysm After PCNL
20. juli 2026 opdateret af: Malkhasyan Vigen Andreevich, Botkin Hospital
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Nikita Astakhov
- Telefonnummer: +7 (968) 490-46-72
- E-mail: botkinhospital@zdrav.mos.ru
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
N/A
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with renal artery pseudoaneurysm after PCNL
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically)
Tidsramme: 1 month
|
1 month
|
|
the proportion of patients with pseudoaneurysm who have the risk factors identified by the study.
Tidsramme: 1 month
|
1 month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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).
Tidsramme: 1 year
|
1 year
|
|
Volume of blood loss requiring transfusi
Tidsramme: 1year
|
1year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: 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
- Studieleder: 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
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
9. september 2026
Primær færdiggørelse (Anslået)
7. maj 2027
Studieafslutning (Anslået)
29. maj 2027
Datoer for studieregistrering
Først indsendt
6. maj 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
24. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
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- Urology20261
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