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Clinical Trials/NCT05500625
NCT05500625Not yet recruitingNot Applicable

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

Assiut University0 sites70 target enrollmentStarted: August 30, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
70
Primary Endpoint
Time of procedure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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) >
  • •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

Arms & Interventions

EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

Experimental

Intervention: Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection (Procedure)

Ballon-occluded retrograde transvenous obliteration

Experimental

Intervention: Ballon-occluded retrograde transvenous obliteration (Procedure)

Outcomes

Primary Outcomes

Time of procedure

Time Frame: 1 day

Time of the whole procedure of EUS and BRTO

Gastric varices bleeding control

Time Frame: 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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara Mohammed Mahrous Sayed

Principal Investigator

Assiut University

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