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CirrhosisEUS; PSENCT07354789

The Feasibility, Safety, and Efficacy of EUS-Guided PSE: A Cohort Study

A study testing EUS guided PSE in people with Cirrhosis and Portal Hypertension, run by Qilu Hospital of Shandong University.

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

Bleeding from esophagogastric varices in patients with liver cirrhosis is often life-threatening. Thrombocytopenia caused by hypersplenism secondary to portal hypertension is an independent risk factor for such gastrointestinal bleeding. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cirrhosis, Portal Hypertension, Bleeding
What is being tested?
EUS guided PSE
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
20 Jan 2026to 15 Mar 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-80 years.
  • Diagnosis of liver cirrhosis based on clinical, laboratory, and imaging examinations.
  • Complicated with gastrointestinal bleeding caused by esophagogastric varices.
  • Patients with hypersplenism and thrombocytopenia (platelet count < 100 × 10^9/L).

Who cannot join

  • Patients who have previously undergone splenectomy, PSE, transjugular intrahepatic portosystemic shunt (TIPS), varicocelectomy, sclerotherapy, or balloon-occluded retrograde transvenous obliteration.
  • Hepatocellular carcinoma or other malignant tumors.
  • Patients with hepatic encephalopathy who are unable to cooperate, or those with liver failure or a Child-Pugh score >13.
  • Patients with allergies to intravenous anesthetics.
  • Patients with unstable vital signs, associated organ dysfunction, active infection, or cardiopulmonary insufficiency, who cannot tolerate endoscopy.
  • Patients who are unable or unwilling to provide informed consent.
  • Uncorrectable coagulation disorders (INR >1.5 and/or fibrinogen <120 mg/dL) or uncorrectable thrombocytopenia (platelet count <20 × 10^9/L).
  • Patients who have used beta-blockers within the past 24 hours

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Guanjun Kou, PhD contact

86+18560086107

kouguanjun88@126.com

About this study

Official title: The Feasibility, Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Partial Splenic Embolization(PSE): A Cohort Study

Bleeding from esophagogastric varices in patients with liver cirrhosis is often life-threatening. Thrombocytopenia caused by hypersplenism secondary to portal hypertension is an independent risk factor for such gastrointestinal bleeding. Studies have confirmed that partial splenic embolization (PSE) can effectively reduce portal pressure and decrease the risk of rebleeding.

Traditional treatments mainly include total splenectomy and X-ray-guided transarterial partial splenic embolization (X-PSE). Although total splenectomy can completely remove the lesion, its application is limited by issues such as increased risks of postoperative infection, thrombosis, and long-term immune dysfunction. Currently, X-PSE has become the mainstream treatment. This technique involves superselective catheterization of the splenic artery branches using a microcatheter and injecting embolic microspheres to achieve partial splenic embolization, thereby preserving partial splenic function. However, X-PSE relies on radiological intervention techniques and carries risks such as radiation exposure, contrast-induced nephropathy, and non-target embolization (e.g., pancreatic necrosis). Additionally, its ability to locate small arterial branches in the splenic hilum is limited.

Read more

Endoscopic ultrasound (EUS) integrates an ultrasound probe at the tip of an endoscope, enabling high-resolution imaging and fine-needle aspiration therapy of the pancreas, gastrointestinal tract, posterior mediastinum, and retroperitoneal structures. With color Doppler functionality, EUS can clearly identify abdominal vessels and their blood flow signals. Since the spleen and splenic vessels are located posterior to the gastric fundus, EUS can clearly visualize the vascular structures of the splenic hilum via a transgastric approach.

Compared to X-PSE, EUS-guided PSE offers the following advantages: a shorter puncture path; avoidance of iodinated contrast agents, making it suitable for patients with iodine allergies or renal insufficiency; no X-ray exposure for patients or operators; the ability to combine treatment for esophagogastric varices in the same procedure, thereby simplifying the process, reducing costs, and shortening hospital stays; and, since there is no arterial puncture site on the body surface, patients do not require prolonged limb immobilization postoperatively, resulting in an overall better healthcare experience.

Current literature and small-sample retrospective studies have reported on this technique, but the included cases are mostly limited to patients with mild liver function impairment, and there is a lack of systematic evaluation of its effect on portal pressure reduction.

The investigators' center integrates the advantages of EUS and X-PSE to perform EUS-guided transgastric puncture for precise injection of embolic materials into the splenic artery branches in patients with liver cirrhosis, gastrointestinal bleeding, and hypersplenism, achieving partial splenic embolization. This study aims to evaluate the safety and efficacy of EUS-guided PSE. The primary endpoint is safety, including the incidence of complications such as intraoperative bleeding, postoperative fever, and abdominal pain scores. Secondary endpoints include efficacy indicators: platelet count, portal pressure gradient, embolization area on CT, incidence of gastrointestinal rebleeding, as well as hospitalization costs and length of stay.

Being tested
EUS guided PSE
Medical subject headings
Fibrosis, Hypertension, Portal, Hemorrhage

What participants receive

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

  • EUS guided PSEProcedure or surgery

    The patients accepted PSE via EUS

Study groups in NCT07354789
Study groupRoleWhat they receive
EUS-PSEExperimentalthe patients undergo the PSE via EUS
Receives: Procedure: EUS guided PSE

What is being measured

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

  1. The incidence of intraoperative bleeding

    The number and rate of patients with intraoperative bleeding.

    Measured: During the EUS-PSE

  2. Postoperative fever

    The highest temperature (Celsius degree) of postoperative fever in the patient

    Measured: Within one month after the EUS-PSE

  3. Duration of abdominal pain

    The duration of the pain (days).

    Measured: Within one month after the EUS-PSE

  4. The incidence of recurrent gastrointestinal bleeding

    The frequency of esophageal and gastric venous bleeding within six months

    Measured: 6 months after the EUS-PSE

Secondary outcomes (1)
  1. Pressure measurements

    The numerical value of Inferior vena cava pressure (mmHg)、hepatic vein pressure (mmHg)、portal pressure measured pressure (mmHg)、free hepatic venous pressure (mmHg)、wedged hepatic venous pressure (mmHg) via EUS.

    Measured: Before EUS-PSE

Timeline

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

  1. First posted21 Jan 2026
  2. Study start20 Jan 2026 (estimated)
  3. Primary completion24 Dec 2026 (estimated)
  4. Study completion15 Mar 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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07354789
Sponsor's protocol ID
2025048
Acronym
EUS; PSE
Status last verified
Dec 2025
First submitted
1 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing EUS guided PSE in people with Cirrhosis and Portal Hypertension, run by Qilu Hospital of Shandong University.

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 8 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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 intraoperative bleeding (time frame: During the EUS-PSE). The study lists 4 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 21 Jan 2026.

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