Efficacy and Safety of Contrast EUS-Guided Tissue Glue/Coil Devascularization vs. BRTO for Preventing Recurrent Gastric Variceal Bleeding

NCT07049146 | Not Yet Recruiting

• 1 other identifier: 2025 Audit No. 670
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of EUS-guided tissue glue/coil injection and BRTO in preventing rebleeding of gastric varices (GVs) in patients with portal hypertension and GVs (including those with esophageal varices, ascites, or hepatic encephalopathy). The main questions it aims to answer are: Is the 1-year all-cause rebleeding rate of EUS-guided tissue glue/coil injection for GVs non-inferior to that of the BRTO group? Does EUS-guided tissue glue/coil injection differ from BRTO in the incidence of decompensated portal hypertension events (variceal bleeding, overt hepatic encephalopathy, ascites) and survival rate post-treatment? Researchers will compare patients randomized 1:1 to the EUS-guided tissue glue/coil injection arm vs. the BRTO arm to see if there are differences in rebleeding rates and complications. Participants will: Receive EUS-guided tissue glue/coil injection or BRTO. Take carvedilol long-term (if no contraindications) to reduce portal pressure. Undergo follow-up assessments at 1, 3, 6, and 12 months ±7 days.

Conditions

Gastric Varices Bleeding

Outcome Measures

Primary Outcomes (1)

• One-year all-cause rebleeding rate

  The rate of upper gastrointestinal bleeding occurring within one year after the operation, regardless of the cause

  one year

Study Arms (2)

EUS-guided tissue glue/coil injection arm

EXPERIMENTAL

Under linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure.

Procedure: EUS-guided tissue glue/coil injection

BRTO arm

ACTIVE COMPARATOR

Establish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure.

Procedure: BRTO

Interventions

EUS-guided tissue glue/coil injection PROCEDURE

Under linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure.

EUS-guided tissue glue/coil injection arm

BRTO PROCEDURE

Establish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure.

BRTO arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years old;
• Liver cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
• Experienced bleeding of gastroesophageal varices (GVs) (GOV1, GOV2, or IGV1) within 5 days to 1 year (bleeding lesions observed under endoscopy originating from GVs, or no other bleeding lesions except GVs were found);
• Presence of spontaneous portosystemic shunts that are technically feasible for BRTO; ⑤ Willing to participate in this clinical study, comply with the study requirements, and sign the informed consent form.

You may not qualify if:

• Previously received vascular interventional therapy for preventing rebleeding of GVs;
• Eligible for variceal ligation treatment of GOV1;
• Non-cirrhotic portal hypertension (including regional portal hypertension);
• Previously underwent surgical and interventional shunt procedures;
• Presence of contraindications to endoscopic or interventional treatment; ⑥ Extensive portal vein thrombosis, cavernous transformation of the portal vein;
• ⑦ Massive ascites;
• ⑧ Concurrent advanced liver cancer or other malignant tumors with a predicted lifespan of less than 3 months;
• ⑨ Concurrent severe diseases of other organs such as the heart, lungs, and kidneys;
• ⑩ Pregnant or lactating women.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

37 Guoxue Lane

Chengdu, Sichuan, 610041, China

Location

Central Study Contacts

Jinlin Yang

CONTACT

+86 18980602058; yangjinlin@wchscu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 3, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)