Portal pressure changes after banding or sclerotherapy for esophageal varices
The Comparative Study on the Alteration of Endoscopic Ultrasound Guided Portal Pressure Gradient in Esophageal Varices After Ligation and Sclerotherapy
This will test whether endoscopic band ligation or sclerotherapy changes portal pressure measured by endoscopic ultrasound in adults with cirrhosis and esophagogastric varices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT07253090 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study will measure portal pressure using endoscopic ultrasound-guided PPG before and after endoscopic ligation or sclerotherapy in cirrhotic patients with esophagogastric varices. Eligible hospitalized adults undergoing primary or secondary prevention will receive standard endoscopic therapy and have PPG recordings taken peri-procedurally. The trial will compare pressure changes between ligation and sclerotherapy and relate findings to clinically significant portal hypertension thresholds. Key exclusions include significant coagulopathy, very low platelets, recent use of propranolol/carvedilol, and extreme age, and all procedures are done at the enrolling hospital in Hangzhou.
Who should consider this trial
Good fit: Adults aged 18–80 with cirrhosis admitted for primary or secondary prevention of esophagogastric varices who can give informed consent and meet clotting and medication criteria are ideal candidates.
Not a fit: Patients with INR >1.5, platelets <20,000/µL, recent propranolol/carvedilol use, those outside the 18–80 age range, or those unwilling to consent are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could clarify whether endoscopic therapies alter portal pressure and help clinicians choose treatments to lower bleeding risk.
How similar studies have performed: Non-selective beta-blockers and TIPS are known to reduce portal pressure, but evidence that endoscopic ligation or sclerotherapy changes portal hemodynamics is limited and EUS-guided portal pressure measurement is a relatively new technique with only preliminary validation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Meng Xue
- Email: xuemeng@zju.edu.cn
- Phone: +86 0571 87783544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.