EUS-PPG Alteration After Ligation and Sclerotherapy in Esophageal Varices

NCT ID: NCT07253090

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EUS-PPG alteration in esophageal varices after ligation

Group Type: OTHER

Ligation for esophageal varices

Intervention Type: PROCEDURE

EUS-PPG alteration in esophageal varices after Ligation

EUS-PPG alteration in esophageal varices after sclerotherapy

Group Type: EXPERIMENTAL

Sclerotherapy for esophageal varices

Intervention Type: PROCEDURE

EUS-PPG alteration in esophageal varices after sclerotherapy

Interventions

Sclerotherapy for esophageal varices

EUS-PPG alteration in esophageal varices after sclerotherapy

Intervention Type: PROCEDURE

Ligation for esophageal varices

EUS-PPG alteration in esophageal varices after Ligation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Cirrhotic patients admitted for primary/secondary prevention due to esophageal and gastric varices, and willing to sign the informed consent form.

Exclusion Criteria

1. Refusing to sign the informed consent form;

2. Age < 18 years, or ≥ 81 years;

3. Coagulopathy (INR > 1.5);

4. Markedly decreased platelets (<20,000/μL);

5. Propranolol/carvedilol was used 24h before admission.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Meng Xue

Role: CONTACT

xuemeng@zju.edu.cn

+86 0571 87783544

Other Identifiers

2025-0708

Identifier Type: -

Identifier Source: org_study_id