EUS-guided Glue Injection for Varices Study

NCT02672319 | Completed

• 1 other identifier: EUS Glue Study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bleeding from gastroesophageal varices is one of the major complications of cirrhosis. After successful treatment of the acute bleeding episode, patients who do not receive follow-up treatment to prevent rebleeding were reported to have a rebleeding rate of 60% within 1- 2 years. The presence of liver cancer and/or portal vein thrombosis has been associated with recurrent variceal bleeding. In a study of liver cancer patients in Hong Kong, 7.9% of patients developed at least 1 episode of variceal bleeding over the course of liver cancer. In patients with portal hypertension from cirrhosis, current guidelines recommend non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial bleeding, and either cyanoacrylate injection for variceal obturation or transjugular intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is unclear whether the above strategies will have the same clinical effect for patients with liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding. Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection for variceal obturation has been described. In a study of patients with gastric variceal bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all patients and 96% of the gastric varices remained obliterated during the follow-up period. To date, there has been no dedicated study to evaluate the role of EUS guided glue injection for prevention of future bleeding in patients at high risk for recurrent variceal bleeding such as those with liver cancer or portal vein thrombosis. The investigators propose this study to evaluate the feasibility and safety of EUS guided glue injection for follow-up variceal treatment in patients at high risk for recurrent variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.

Conditions

Gastroesophageal Varices

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate

  Number of participants who undergo EUS guided glue injection and develop rebleeding during the 3-month and 6-month follow up period

  6 months

Secondary Outcomes (3)

• bleeding free interval after index procedure

  12 months

• Technical success

  At time of procedure

• procedural complication

  12 months

Study Arms (2)

EUS-guided glue injection

EXPERIMENTAL

Gastroesophageal varices \> 3mm in diameter will be treated with EUS guided cyanoacrylate injection for variceal obturation in standard fashion. A conventional 19G needle (19G-Echotip needle, Cook Medical, USA) will be advanced into the target varix under real-time EUS guidance. Cyanoacrylate injection (Histoacryl, B. Braun Surgical, Germany) will be performed according to established protocol. Each aliquot of cyanoacrylate injection will consist of 0.5ml of Histoacryl + 0.7ml of lipiodol. 1 - 3 aliquots of cyanoacrylate injection may be given depending on the number of varices needed to be treated. EUS with colour Doppler will be used to monitor obliteration of blood flow in varices during and after cyanoacrylate injection.

Procedure: EUS-guided glue injection

Historical control

NO INTERVENTION

A historical control group of HCC patients with gastroesophageal variceal bleeding who underwent conventional cyanoacrylate injection by OGD for index variceal bleeding based on de-identified data from an existing prospective GI bleed database from 2009-2013 would also be included to allow a more meaningful interpretation of the rebleeding rate from gastroesophageal varices from this study.

Interventions

EUS-guided glue injection PROCEDURE

Experimental: EUS-guided glue injection Gastroesophageal varices \> 3mm in diameter will be treated with EUS guided cyanoacrylate injection for variceal obturation in standard fashion. A conventional 19G needle (19G-Echotip needle, Cook Medical, USA) will be advanced into the target varix under real-time EUS guidance. Cyanoacrylate injection (Histoacryl, B. Braun Surgical, Germany) will be performed according to established protocol. Each aliquot of cyanoacrylate injection will consist of 0.5ml of Histoacryl + 0.7ml of lipiodol. 1 - 3 aliquots of cyanoacrylate injection may be given depending on the number of varices needed to be treated. EUS with colour Doppler will be used to monitor obliteration of blood flow in varices during and after cyanoacrylate injection.

EUS-guided glue injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients with hepatocellular carcinoma (liver cancer), and/or portal vein thrombosis, who have presented with gastroesophageal variceal bleeding within 12 weeks
• Age \> 18 years
• Written informed consent available

You may not qualify if:

• Contraindications for endoscopy due to comorbidities
• Unable to provide written informed consent
• Refractory coagulopathy (INR\>1.5) or refractory thrombocytopenia (platelets \<50,000) despite blood product transfusion
• Pregnant patients
• Moribund patients from terminal illnesses

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

• Raymond S Tang, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Comparison of clinical outcomes of a prospective study cohort to those in a historical control group

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: February 3, 2016
• Study Start: April 1, 2014
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)