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EUS-PPG Alteration After Ligation and Sclerotherapy in Esophageal Varices

NCT07253090 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-11-28

No results posted yet for this study

Summary

Acute variceal bleeding due to cirrhotic portal hypertension is a life-threatening emergency in gastroenterology. Current preventive strategies include non-selective β-blockers (e.g., carvedilol/propranolol), endoscopic therapy (sclerotherapy or band ligation), and transjugular intrahepatic portosystemic shunt (TIPS). While pharmacological and TIPS interventions directly reduce portal pressure, the impact of endoscopic therapies on portal hemodynamics remains controversial. The hepatic venous pressure gradient (HVPG), measured via transjugular catheterization as the difference between wedged and free hepatic venous pressures, is the gold standard for assessing portal pressure. Clinically significant portal hypertension (CSPH) is defined as HVPG ≥10 mmHg, with values \>12 mmHg predicting variceal formation and bleeding risk.

Traditional views suggest that non-selective β-blockers and transjugular intrahepatic portosystemic shunt (TIPS) can reduce portal vein pressure. Does endoscopic intervention affect portal vein pressure? Previous studies have explored changes in HVPG in the acute phase after esophageal variceal sclerotherapy and ligation therapy, with inconsistent results. In the study by Toyonaga et al., HVPG was rechecked 2 weeks after sclerotherapy, and the average decreased from 17.9 mmHg to 17.6 mmHg (J Hepatol. 1994 Oct;21(4):515-20). In the study by Gonzalo Bada et al., HVPG values increased from 16.5 mmHg to 19.5 mmHg on average 24 hours after ligation therapy (Rev Esp Enferm Dig. 2020 Jun;112(6):456-461). However, in a prospective randomized controlled study conducted by Avgerinos et al., which compared changes in HVPG within 5 days after ligation and sclerotherapy, and found that HVPG significantly increased after sclerotherapy, while there was no significant change in HVPG after ligation (Hepatology. 2004 Jun;39(6):1623-30).

The investigators speculate that the inconsistent results mentioned above may be related to the limitations of HVPG, which inaccurately reflects pre-sinusoidal/extrahepatic portal hypertension and is influenced by technical factors (e.g., catheter position, sedation). Emerging evidence suggests endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement may overcome these limitations. Recent studies demonstrate strong correlations between EUS-PPG and HVPG, as well as associations with variceal severity and Child-Pugh class. However, data on chronic portal pressure changes (≥3 months) post-endoscopic therapy are lacking.

This prospective study aims to evaluate chronic changes in EUS-PPG 3-6 months after endoscopic variceal ligation (EVL) or sclerotherapy in cirrhotic patients receiving primary/secondary prophylaxis.

Conditions

  • Esophagogastric Varices

Interventions

PROCEDURE

Sclerotherapy for esophageal varices

EUS-PPG alteration in esophageal varices after sclerotherapy

PROCEDURE

Ligation for esophageal varices

EUS-PPG alteration in esophageal varices after Ligation

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253090 on ClinicalTrials.gov