Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices

Not Applicable

Not yet recruiting

• Conditions: Gastric Varix
• Interventions: Procedure: Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection; Procedure: Ballon-occluded retrograde transvenous obliteration

• Registration Number: NCT05500625
• Lead Sponsor: Assiut University

Brief Summary

Gastrointestinal bleeding is a common complication of liver cirrhosis which caused by esophageal and gastric varices. The risk of bleeding from gastric varices is relatively low. However, the bleeding is usually significant and severe.

Current guidelines recommend endoscopic glue injection as the first line of treatment for gastric variceal bleeding.

Although this technique has been shown to be effective, it is associated with many severe adverse events including systemic embolization, fever, chest pain, and even death. The rate of hemostasis has been reported to be as high as 91-100% but the rebleeding rate from gastric varices still present.

Endoscopic ultrasound (EUS) guided therapy has recently been introduced as a more effective and safer option than endoscopic therapy for gastric varices. EUS-guided therapy includes EUS guided Cyanoacrylate injection alone or in combination with EUS-guided coiling. It offers the advantage of directly visualizing the varices and delivering targeted therapy.

A standard endoscopic examination only allows the evaluation of superficial varices. The use of Endoscopic ultrasound facilitates evaluation of peri-gastric and perforating vessels, which are directly involved in variceal development. EUS also facilitates accurate placement of the coil and preserves the naturally formed splenorenal shunt.

Balloon-occluded retrograde transvenous obliteration(BRTO) has been reported to achieve satisfactory bleeding control rates for isolated gastric varices with High hemostasis rates and low rebleeding rate.

Despite all these promising results, there are scarce studies describing and comparing the efficacy of EUS-guided therapy and BRTO in patients with gastric varices. Further prospective comparative studies are needed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-29
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-13
• Study First Posted: 2022-08-15
• Last Update Posted: 2022-08-16
• Study Start: 2022-08-30
• Primary Completion: 2024-08-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Presence of fundal gastric varices either: High risk for rupture; diagnosed by upper endoscopy i.e. large size or presence of red color spot.

Bleeding varices; diagnosed by upper endoscopy with good hemostasis achieved with endoscopic treatment.

Bleeding varices; diagnosed by upper endoscopy but hemostasis could not be achieved with endoscopic treatment.

• Fundal gastric varices with Presence of contraindication for TIPS such as repeated attacks of hepatic encephalopathy due to Portosystemic shunt, Model of End Stage Liver disease score (MELD) >18.
• Fundal varices with catheterizable portosystemic shunt such as gastrorenal shunt or gastrocaval shunt.

Exclusion Criteria

• Complete portal vein thrombosis
• Splenic vein thrombosis
• Intractable ascites (TIPS is better)
• Uncontrolled esophageal varices (high risk for bleeding) and TIPS is better

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-guided coil embolization combined with endoscopic cyanoacrylate injection	Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection	-
Ballon-occluded retrograde transvenous obliteration	Ballon-occluded retrograde transvenous obliteration	-

Primary Outcome Measures

Name	Time	Method
Time of procedure	1 day	Time of the whole procedure of EUS and BRTO
Gastric varices bleeding control	7 days	Teatment using EUS- guided coil with cyanoacrylate injection in group of patients and other group treatment using Balloon-Occluded Retrograde Transvenous Obliteration Gastric varices bleeding control within 1 week The parameter will be assesed is incidence of bleeding after the procedure number of attacks of haematemsis and melena)