Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient

NCT ID: NCT07062289

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-06-30

Brief Summary

This study aims to evaluate the accuracy and safety of a novel endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement technique in 42 adults with liver cirrhosis and portal vein thrombosis (blood clots in the liver's main vein), a condition where current standard testing (HVPG) fails to provide reliable pressure readings. Participants will undergo both EUS-PPG (using a specialized needle under ultrasound guidance) and HVPG procedures to compare results; EUS-PPG will be performed under general anesthesia in a left-side lying position-an innovative approach-while also enabling immediate endoscopic treatment of bleeding veins if detected during the same session. The primary goals are to validate EUS-PPG's safety in this high-risk group, establish its correlation with HVPG, and pioneer an integrated diagnosis-treatment protocol to reduce hospital stays and costs. The study runs from July 2025 to June 2027 at Zhejiang University School of Medicine.

Conditions

Portal Vein Thrombosis; Portal Hypertension Related to Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

hepatic venous pressure gradient, HVPG

After puncturing the internal jugular vein, under the guidance of the image monitor, the balloon catheter is inserted into the hepatic vein along the blood vessel to measure the free hepatic venous pressure (FHVP), and then the balloon is inflated to measure the wedged hepatic venous pressure (WHVP). The difference between the two is the hepatic venous pressure gradient.

Group Type: EXPERIMENTAL

endoscopic ultrasound-guided portal pressure gradient

Intervention Type: PROCEDURE

This study employs an integrated endoscopic ultrasound-guided portal pressure gradient (EUS-PPG+) protocol uniquely designed for cirrhotic patients with portal vein thrombosis (PVT). Under general anesthesia in the left lateral decubitus position (novel positioning), a linear echoendoscope directs 22G needle puncture of the portal vein and inferior vena cava for direct pressure measurement, with real-time Doppler confirmation to avoid thrombosed vessels. Crucially, this intervention synchronizes diagnostic and therapeutic actions: if high-risk esophageal/gastric varices are identified during EUS, immediate endoscopic therapy (e.g., glue injection) is delivered in the same session. All participants additionally undergo standard hepatic venous pressure gradient (HVPG) measurement via transjugular access within 24 hours, enabling within-patient correlation analysis.

Interventions

endoscopic ultrasound-guided portal pressure gradient

This study employs an integrated endoscopic ultrasound-guided portal pressure gradient (EUS-PPG+) protocol uniquely designed for cirrhotic patients with portal vein thrombosis (PVT). Under general anesthesia in the left lateral decubitus position (novel positioning), a linear echoendoscope directs 22G needle puncture of the portal vein and inferior vena cava for direct pressure measurement, with real-time Doppler confirmation to avoid thrombosed vessels. Crucially, this intervention synchronizes diagnostic and therapeutic actions: if high-risk esophageal/gastric varices are identified during EUS, immediate endoscopic therapy (e.g., glue injection) is delivered in the same session. All participants additionally undergo standard hepatic venous pressure gradient (HVPG) measurement via transjugular access within 24 hours, enabling within-patient correlation analysis.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• History of liver cirrhosis
• INR < 1.5
• Platelet count > 50 × 10⁹/L
• Patients agreed to HVPG and EUS-PPG measurements

Exclusion Criteria

• Patients with ascites
• Patients with renal insufficiency
• Patients with active infection
• Patients with hepatic encephalopathy
• Critically ill patients
• Pregnant patients
• Patients with immunodeficiency diseases (such as systemic lupus erythematosus)
• Patients with mental illness
• Patients with malignant tumors
• Patients who refused to undergo HVPG and EUS-PPG measurements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Zheng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wei Wei

Role: CONTACT

wwze@zju.edu.cn

17530861504

References

Martinez-Moreno B, Martinez Martinez J, Herrera I, Guilabert L, Rodriguez-Soler M, Bellot P, Miralles C, Pascual S, Irurzun J, Zapater P, Palazon-Azorin JM, Gil Guillen V, Jover R, Aparicio JR. Correlation of endoscopic ultrasound-guided portal pressure gradient measurements with hepatic venous pressure gradient: a prospective study. Endoscopy. 2025 Jan;57(1):62-67. doi: 10.1055/a-2369-0759. Epub 2024 Jul 18.

Reference Type: RESULT

PMID: 39025130 (View on PubMed)

Zhang W, Peng C, Zhang S, Huang S, Shen S, Xu G, Zhang F, Xiao J, Zhang M, Zhuge Y, Wang L, Zou X, Lv Y. EUS-guided portal pressure gradient measurement in patients with acute or subacute portal hypertension. Gastrointest Endosc. 2021 Mar;93(3):565-572. doi: 10.1016/j.gie.2020.06.065. Epub 2020 Jun 29.

Reference Type: RESULT

PMID: 32615178 (View on PubMed)

Other Identifiers

2025-0823

Identifier Type: -

Identifier Source: org_study_id