EUS-guided Embolization of the Visceral Artery Aneurysm

Official title

The Safety and Feasibility of EUS-Guided Embolization for Visceral Artery Aneurysms: A Cohort Study

Overview

Visceral Artery Aneurysm (VAA) refers to a localized or diffuse dilation or bulging of the arterial wall in the arteries supplying the gastrointestinal tract, liver, spleen, and pancreas (celiac trunk, superior mesenteric artery, inferior mesenteric artery, and their branches), caused by various pathological conditions or injuries. Among these, splenic artery aneurysms (60%) and hepatic artery aneurysms (20%) are the most common. Similar to cerebral aneurysms and aortic aneurysms, visceral artery aneurysms are a serious vascular disease that threatens human life, with an incidence of 0.2% to 2.0% in the population, second only to abdominal aortic aneurysms and iliac artery aneurysms. The main etiologies include atherosclerosis, degeneration of the arterial media, infection, fibromuscular dysplasia, congenital abnormalities, trauma, and arteritis. The incidence of visceral artery aneurysms ranges from 0.01% to 0.20%. Although the incidence is relatively low, the rupture rate can be as high as 25%, often leading to hemorrhagic shock or even death. The treatment of VAA primarily includes open surgical procedures such as aneurysm resection and vascular reconstruction, as well as endovascular interventions such as aneurysm embolization and covered stent graft placement. Endovascular embolization is the first-line treatment for VAA. This procedure involves puncturing the femoral artery using the Seldinger technique, advancing a microcatheter near the affected vessel, injecting high-pressure iodinated contrast to visualize the lesion, and then superselecting into the aneurysm or adjacent vessels to embolize the aneurysm or its outflow tract using coils or tissue adhesive. However, X-ray-guided treatment is relatively expensive and involves complex steps. Additionally, for small aneurysms, aneurysms with narrow necks, tortuous vessels, or patients allergic to iodine, surgical resection of VAA may be the only option. Surgical procedures are associated with significant trauma, high costs, and multiple complications. Endoscopic Ultrasound (EUS) involves an ultrasound probe attached to the tip of an endoscope, allowing imaging and fine-needle aspiration of the pancreas, gastrointestinal tract, posterior mediastinum, and retroperitoneum. Linear EUS can also identify abdominal vessels and blood flow signals via color Doppler. Therefore, after localizing the VAA with EUS, a fine-needle aspiration needle is advanced into the aneurysm. Through the needle tract, a 0.035-inch or 0.018-inch coil is deployed, and tissue adhesive is injected under direct visualization until the aneurysm is completely embolized (Figure 1). This technique has been reported in international literature.

Interventions

• Procedure EUS-guided VAA
  The patients accepted embolization of VAA via EUS

Primary outcome measures

• The incidence of bleeding [Time frame: Intraoperative and within 3 days after the embolism]
• Incidence of pancreatitis after EUS-guided VAA procedure [Time frame: Within 3 days after the embolism]
• Technical success rate of embolization in EUS-guided VAA [Time frame: Immediately post the embolization]

Secondary outcome measures (2)

• The gender of the patients [Time frame: Baseline]
• Etiology of VAA [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• Patients aged 18-60 years diagnosed with VAA by CT, MRI, or EUS.
• VAA presenting with any symptoms such as abdominal pain or compression; any asymptomatic VAA located in gastric, gastroepiploic, pancreaticoduodenal, gastroduodenal, mesenteric, or colonic arteries; asymptomatic splenic, renal, hepatic, celiac, jejunal, or ileal artery aneurysms with a diameter >2 cm; any asymptomatic VAA with an annual maximum diameter increase >0.5 cm/year; or female patients of childbearing age with VAA.
• Patients who are allergic to iodinated contrast or are pregnant, and thus are unsuitable for endovascular intervention.
• VAA that is accessible and identifiable by EUS

Exclusion criteria

• Patients with unstable vital signs or those accompanied by major organ dysfunction, severe coagulation disorders (INR >1.5), active infection, or cardiopulmonary insufficiency, rendering them unable to tolerate endoscopic examination.
• Patients with uncorrectable coagulation disorders (PT-INR <1.5 and/or fibrinogen <120 mg/dL) or uncorrectable thrombocytopenia (platelet count <20 × 10⁹/L).
• Patients with a known allergy to intravenous anesthetic agents.
• Patients who have previously undergone surgical, interventional, or EUS-guided treatment for VAA.
• Patients unable to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07490678 · 2025039

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗