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Renal Artery Pseudoaneurysm After PCNL

ConditionArtery Pseudoaneurysm After PCNL
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBotkin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients with renal artery pseudoaneurysm after PCNL

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Embolization of a renal artery branch pseudoaneurysm

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients with renal artery pseudoaneurysm after PCNL1 intervention

Trial outcomes

Primary outcomes

1

The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically)

Time frame
1 month
2

the proportion of patients with pseudoaneurysm who have the risk factors identified by the study.

Time frame
1 month

Secondary outcomes

1

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
2

Volume of blood loss requiring transfusi

Time frame
1year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Botkin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: