Comparing EUS-guided and conventional therapy to prevent rebleeding in liver cancer patients
Secondary Prevention of Variceal Rebleeding by Endoscopic Ultrasound-guided Therapy Versus Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients: a Randomized Controlled Trial
This study is testing whether a new ultrasound-guided treatment can better prevent rebleeding in liver cancer patients compared to the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT05629845 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of endoscopic ultrasound (EUS)-guided therapy versus conventional endoscopic therapy in preventing variceal rebleeding in patients with hepatocellular carcinoma (HCC). It focuses on patients who have recently experienced variceal bleeding and have had their bleeding controlled through standard endoscopic methods. The study will compare the rates of rebleeding following these two therapeutic approaches, with a particular emphasis on the high-risk population of HCC patients. The methodology involves a multicenter approach to gather comprehensive data on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are HCC patients aged 18 or older who have recently experienced and successfully controlled variceal bleeding.
Not a fit: Patients who may not benefit from this study include those with non-variceal sources of gastrointestinal bleeding or severe comorbidities that contraindicate endoscopy.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of rebleeding in HCC patients, improving their overall survival and quality of life.
How similar studies have performed: Previous studies have shown promising results with EUS-guided therapies in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive HCC patients age 18 or older with recent (within 4 weeks of the episode) EV or GV bleeding successfully controlled by conventional endoscopic therapies (VBL for EV or glue injection for GV) * Able to provide written informed consent to participate in the study and comply with the study procedures Exclusion Criteria: * Unable to provide written informed consent * Contraindications for endoscopy due to underlying comorbidities * HCC patients with non-variceal source of gastrointestinal bleeding * Refractory coagulopathy (INR\>1.5) or refractory thrombocytopenia (platelets \<50,000) despite blood product transfusion * Moribund patients from terminal illness
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital, The Chinese University of Hong Kong — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Raymond S Tang, MD — Chinese University of Hong Kong
- Study coordinator: Raymond S Tang, MD
- Email: raymondtang@cuhk.edu.hk
- Phone: (852) 26370428
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.