EUS-guided Embolization of the Visceral Artery Aneurysm (EUS)

March 22, 2026 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

  1. 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.
  2. Patients with uncorrectable coagulation disorders (PT-INR <1.5 and/or fibrinogen <120 mg/dL) or uncorrectable thrombocytopenia (platelet 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 informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EUS-VAA
EUS-guided embolization of the Visceral artery aneurysm
Procedure: EUS-guided VAA
The patients accepted embolization of VAA via EUS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of bleeding
Time Frame: Intraoperative and within 3 days after the embolism
The number and rate of patients with bleeding during and post-operation.
Intraoperative and within 3 days after the embolism
Incidence of pancreatitis after EUS-guided VAA procedure
Time Frame: Within 3 days after the embolism
The number and rate of patients with pancreatitis after EUS-guided VAA procedure.
Within 3 days after the embolism
Technical success rate of embolization in EUS-guided VAA
Time Frame: Immediately post the embolization
The rate of successful complete embolization of visceral artery aneurysm confirmed by immediate EUS evaluation after the procedure.
Immediately post the embolization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The gender of the patients
Time Frame: Baseline
Describe the gender of the patients
Baseline
Etiology of VAA
Time Frame: Baseline
Describe the etiology of the VAA
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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