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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bleeding; Cirrhosis; Portal Hypertension
• Intervention / Treatment: Procedure: EUS guided PSE

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guanjun Kou, PhD; Phone Number: 86+18560086107; Email: kouguanjun88@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-PSE; the patients undergo the PSE via EUS	Procedure: EUS guided PSE; The patients accepted PSE via EUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of intraoperative bleeding	The number and rate of patients with intraoperative bleeding.	During the EUS-PSE
Postoperative fever	The highest temperature (Celsius degree) of postoperative fever in the patient	Within one month after the EUS-PSE
Duration of abdominal pain	The duration of the pain (days).	Within one month after the EUS-PSE
The incidence of recurrent gastrointestinal bleeding	The frequency of esophageal and gastric venous bleeding within six months	6 months after the EUS-PSE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before EUS-PSE

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The gender of the patients	Describe the gender of the patients, including male or female	At the time of enrollment
Etiology of cirrhosis	Describe the etiology of the cirrhosis	At the time of enrollment
The age of the patients	The age (years) of the patients.	At the time of enrollment
The number of the platelet	The number of the platelet (x 10^9/L)	Before EUS-PSE and postoperative follow-up (1 month, 3 months, and 6 months post EUS-PSE )

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Hypertension, Portal; Hemorrhage
• Other Study ID Numbers: 2025048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No