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AneurysmEUSNCT07490678

EUS-guided Embolization of the Visceral Artery Aneurysm

A study testing EUS-guided VAA in people with Aneurysm, run by Qilu Hospital of Shandong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Aneurysm
What is being tested?
EUS-guided VAA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
5 Mar 2026to 25 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guanjun Kou, PhD contact

+86-18560086107

kouguanjun88@126.com

China1 site
  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

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

Other trials in China

About this study

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

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.

Conditions
Aneurysm
Being tested
EUS-guided VAA
Medical subject headings
Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-guided VAAProcedure or surgery

    The patients accepted embolization of VAA via EUS

Study groups in NCT07490678
Study groupRoleWhat they receive
EUS-VAAExperimentalEUS-guided embolization of the Visceral artery aneurysm
Receives: Procedure: EUS-guided VAA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of bleeding

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

    Measured: 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.

    Measured: 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.

    Measured: Immediately post the embolization

Secondary outcomes (2)
  1. The gender of the patients

    Describe the gender of the patients

    Measured: Baseline

  2. Etiology of VAA

    Describe the etiology of the VAA

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2026
  2. Study start5 Mar 2026 (estimated)
  3. Primary completion25 Jan 2027 (estimated)
  4. Study completion25 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07490678
Sponsor's protocol ID
2025039
Acronym
EUS
Status last verified
Dec 2025
First submitted
3 Jan 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EUS-guided VAA in people with Aneurysm, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guanjun Kou, PhD (+86-18560086107, kouguanjun88@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of bleeding (time frame: Intraoperative and within 3 days after the embolism). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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