110 Participants NeededMy employer runs this trial

EUS-Guided Coil and Glue for Gastric Varices

Recruiting at 1 trial location
RP
Overseen ByRajesh Puri, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medanta, The Medicity, India
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to treat stomach bleeding caused by liver disease. Currently, doctors use glue to stop the bleeding, but this trial adds small coils to the glue to see if it improves effectiveness. The goal is to reduce the risk of recurrent bleeding and enhance treatment safety. People with liver disease and specific types of stomach bleeding might be suitable candidates for this trial. Participants will receive either the new EUS-guided coil and cyanoacrylate glue injection treatment or the standard endoscopic cyanoacrylate glue injection treatment. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could improve patient outcomes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EUS-guided coil and glue injection is generally safe for treating bleeding in the stomach caused by swollen veins, known as gastric varices. One study found that patients undergoing this procedure experienced fewer side effects compared to those receiving the traditional glue injection. The study also revealed that the EUS-guided method was not only safer but required fewer sessions to achieve full effectiveness. Another study confirmed the safety and feasibility of this approach, even for patients with severe liver disease.

The traditional method, endoscopic glue injection, is already a common treatment for gastric varices. Although complications can occur, it is usually well-tolerated.

Both treatments aim to stop stomach bleeding, a serious issue for people with liver disease. While no treatment is without risks, current evidence suggests that both methods are relatively safe, with the EUS-guided technique offering some safety and effectiveness benefits.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for gastric varices because they offer innovative approaches to managing bleeding. The EUS-guided Coil and Glue Injection combines endoscopic ultrasound with embolization coils followed by cyanoacrylate glue to precisely target and seal bleeding varices, potentially providing more effective and targeted treatment compared to conventional methods. This technique allows for real-time monitoring and follow-up through ultrasound, ensuring complete obliteration of varices. In contrast, the standard Endoscopic Glue Injection applies glue directly onto the varices, which can be effective but lacks the additional precision and monitoring capability of the EUS-guided method. These advancements could lead to improved outcomes and reduced recurrence of bleeding, making them a promising step forward in treatment options.

What evidence suggests that this trial's treatments could be effective for gastric varices?

Research has shown that EUS-guided coil and glue injection, a treatment in this trial, effectively treats gastric varices, which are swollen veins in the stomach. Studies indicate that this method successfully closes these veins about 90.9% of the time. It typically requires fewer repeat procedures compared to using glue alone, the treatment in another arm of this trial. Additionally, the EUS-guided coil and glue treatment is associated with a lower risk of the veins bleeding again. Overall, these findings suggest that combining coils and glue may lead to better outcomes for patients with bleeding gastric varices.26789

Are You a Good Fit for This Trial?

This trial is for adults with liver cirrhosis who are experiencing bleeding from enlarged veins in the stomach (gastric varices). Participants must have active or recent gastric variceal bleeding and be able to undergo endoscopic treatment.

Inclusion Criteria

I am older than 18 years.
I have liver cirrhosis and portal hypertension.
I have or am suspected to have bleeding from specific types of gastric varices (GOV-2 or IGV-1).

Exclusion Criteria

Platelet count < 50,000 /mL and International Normalized Rate (INR) > 2.0
I cannot safely have an endoscopy procedure.
I have shock that does not improve with treatment.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EUS-guided coil and glue injection or conventional endoscopic glue injection for bleeding gastric varices

Varies until complete variceal obliteration
Multiple visits as needed for treatment

Follow-up

Participants are monitored for safety, effectiveness, and rebleeding for 12 months after randomization

12 months
Scheduled follow-up visits with clinical assessment, EUS surveillance, and laboratory investigations

What Are the Treatments Tested in This Trial?

Interventions

  • Endoscopic Cyanoacrylate Glue Injection
  • EUS-guided Coil and Cyanoacrylate Glue Injection

Trial Overview

The study compares two treatments for bleeding gastric varices: one group receives a standard glue injection, while the other gets a combination of coil placement and glue using ultrasound guidance. Patients are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: EUS-guided Coil and Glue InjectionExperimental Treatment1 Intervention
Group II: Endoscopic Glue InjectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medanta, The Medicity, India

Lead Sponsor

Trials
15
Recruited
9,800+

Orlando Health, Inc.

Collaborator

Trials
32
Recruited
15,100+

Citations

EUS-guided coil versus cyanoacrylate therapy for the ...

EUS-guided therapy for GV by using CYA or ECA is effective in localized GV. ECA required fewer endoscopies and tended to have fewer adverse events

EUS-guided angiotherapy for gastric varices: coil, glue, ...

The rates of GVO were comparable at 94.7% and 90.9% for the glue and coil groups, respectively, although complete GVO was more readily achieved in the coil ...

Endoscopic Ultrasound Guided Intervention for Gastric ...

Only 42% of patients had successful treatment after 1 session of EUS-guided glue injection. A mean of 1.5 (SD 0.1) mL of cyanoacrylate was ...

EUS-Guided Coil and Glue vs Glue Injection for Bleeding ...

The primary outcome is all-cause rebleeding at 12 months. Secondary outcomes include technical success in patients with cirrhosis and account ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39389435/

EUS-guided coiling plus glue injection compared with ...

In patients with GVs, EUS-guided coil plus glue injection is associated with lower recurrent bleeding and reintervention rates than EGI with ...

Endoscopic ultrasound-guided placement of coils and ... - PMC

EUS-guided coiling and cyanoacrylate injection is safe and feasible in pediatric patients and could be considered as rescue therapy for treatment of refractory

Endoscopic ultrasound-guided coiling and glue is safe and ...

Endoscopic ultrasound-guided coiling and glue is safe and superior to endoscopic glue injection in gastric varices with severe liver disease:

Technical tips for EUS-guided embolization of varices and ...

EUS-guided embolization of gastric varices reduces the rebleeding rate, need for reintervention, volume of cyanoacrylate, and systemic glue ...

EUS GUIDED COIL AND GLUE IS SUPERIOR TO ...

In this study, we compare the efficacy of EUS guided coil and glue injection with endoscopic glue injection for patients with gastric varices.