Clinical trial NCT06994039: Left Lateral Position and Supine Position in EUS-PPG Measurement
Official title: The Comparative Study on Left Lateral Position and Supine Position in Endoscopic Ultrasound Guided Portal Pressure Gradient Measurement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS)
Varices, Esophageal
Gastric Varices
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The gastroesophageal variceal inpatients admitted for endoscopic therapy

Brief summary: The consistency of EUS-PPG measurements between left lateral decubitus and supine positions is unclear. In this rospective comparative study, we are aimed to evaluate the correlation between EUS-PPG measured in supine position (EUS-suPPG), and EUS-PPG measured in left lateral decubitus position (EUS-lePPG).

Detailed description: The hepatic venous pressure gradient (HVPG) remains the gold standard for assessing portal hypertension, yet its clinical application faces several limitations. First, HVPG has restricted diagnostic scope, being unable to accurately evaluate prehepatic or presinusoidal portal hypertension. Second, the measurement process exposes both patients and physicians to radiation and involves complex techniques that preclude routine implementation in many hospitals. Finally, as HVPG indirectly estimates portal pressure through wedged hepatic venous pressure, its accuracy may be compromised by multiple factors including intrahepatic venous shunting, catheter insertion depth, excessive sedation or patient agitation during the procedure, and incomplete balloon occlusion of hepatic venous flow.

Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement effectively addresses these limitations of HVPG. Current clinical studies on EUS-PPG have predominantly been conducted in the supine position. However, this position significantly increases the technical difficulty of endoscopic ultrasonography and complicates the simultaneous performance of endoscopic selective varices devascularization (EUS-ESVD) under single anesthesia. The consistency of EUS-PPG measurements between left lateral decubitus and supine positions requires further investigation.

This prospective comparative study enrolls hospitalized patients with liver cirrhosis complicated by esophagogastric varices. Prior to endoscopic treatment, we perform EUS-guided puncture of both the portal vein and hepatic vein using a 25G needle. Pressure transducers measure the portal venous pressure (PVP) and hepatic venous pressure (HVP), with their differential defined as EUS-PPG. Measurements obtained in supine position are designated EUS-suPPG, while those in left lateral decubitus position are termed EUS-lePPG. Statistical analysis will evaluate the correlation between EUS-suPPG and EUS-lePPG values, with postoperative monitoring for complications including infection and hemorrhage.

Eligibility criteria: Inclusion Criteria:

* The gastroesophageal variceal patients hospitalized for endoscopic therapy, and are willing to sign the informed consent of measuring portal vein pressure gradient under endocsopic ultrasound.

Exclusion Criteria:

* （1）unwilling to sign the informed consent （2）uncorrectable coagulopathy (INR\>1.5) （3）uncorrectable thrombocytopenia (platelets \<20,000/μL) （4）Bacteremia （5）Age\<18,or≥81 （6）pregnancy

Primary outcomes:
measure: EUS-lePPG
timeFrame: From the begining of the procedure to the end of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Study officials:
References: