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Not yet recruitingNCT07490678EUSUpdated Mar 24, 2026

EUS-guided Embolization of the Visceral Artery Aneurysm

An interventional study of EUS-guided VAA in Aneurysm, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Aneurysm

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03

In context

Aneurysm

381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.

This study's planned enrollment of 30 is below the median of 46 across 235 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients aged 18-60 years diagnosed with VAA by CT, MRI, or EUS.
  2. 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.
  3. Patients who are allergic to iodinated contrast or are pregnant, and thus are unsuitable for endovascular intervention.
  4. VAA that is accessible and identifiable by EUS

Exclusion criteria

Exclusion Criteria:

  1. Patients with unstable vital signs or those accompanied by major organ dysfunction, severe coagulation disorders ( >1.5), active infection, or cardiopulmonary insufficiency, rendering them unable to tolerate endoscopic examination.
  2. Patients with uncorrectable coagulation disorders (PT-INR \<1.5 and/or fibrinogen \<120 mg/dL) or uncorrectable thrombocytopenia ( count \<20 × 10⁹/L).
  3. Patients with a known allergy to intravenous anesthetic agents.
  4. Patients who have previously undergone surgical, interventional, or EUS-guided treatment for VAA.
  5. Patients unable to provide .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    EUS-VAA

    EUS-guided embolization of the Visceral artery aneurysm

    Procedure: EUS-guided VAA

Interventions

  • ProcedureEUS-guided VAA

    The patients accepted embolization of VAA via EUS

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What researchers measure

Primary outcomes

  1. The incidence of bleeding

    The number and rate of patients with bleeding during and post-operation.

    Time frame: Intraoperative and within 3 days after the embolism

  2. Incidence of pancreatitis after EUS-guided VAA procedure

    The number and rate of patients with pancreatitis after EUS-guided VAA procedure.

    Time frame: Within 3 days after the embolism

  3. Technical success rate of embolization in EUS-guided VAA

    The rate of successful complete embolization of visceral artery aneurysm confirmed by immediate EUS evaluation after the procedure.

    Time frame: Immediately post the embolization

Secondary outcomes

  1. The gender of the patients

    Describe the gender of the patients

    Time frame: Baseline

  2. Etiology of VAA

    Describe the etiology of the VAA

    Time frame: Baseline

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07490678
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
Mar 5, 2026 (estimated)
Primary completion
Jan 25, 2027 (estimated)
Completion
Jul 25, 2027 (estimated)
Last update
Mar 24, 2026

Study contacts

Guanjun Kou, PhD
Contact
kouguanjun88@126.com
+86-18560086107

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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