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

NCT05500625 | Unknown

• 1 other identifier: EUSCCIBRTOMPGV
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Varix

Outcome Measures

Primary Outcomes (2)

• Gastric varices bleeding control

  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)

  7 days

• Time of procedure

  Time of the whole procedure of EUS and BRTO

  1 day

Study Arms (2)

EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

EXPERIMENTAL

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

Ballon-occluded retrograde transvenous obliteration

EXPERIMENTAL

Procedure: Ballon-occluded retrograde transvenous obliteration

Interventions

Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection PROCEDURE

Standard diagnostic endoscopy will be done and Fundal varices will be assessed. EUS procedures will be performed using linear endoscope under general anesthesia. Use EUS to assess the anatomy of gastric varices, observe the blood flow, scan the portal venous system, left renal vein, confirm the location of the shunt, and measure the diameter of the shunt. Puncture the gastric fundal variceal vein at the lower esophagus near the cardia and place the coil into the shunt and immediately inject with sclerosant and cyanoacrylate under the guidance of EUS using a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. Use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect.

Also known as: EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

Ballon-occluded retrograde transvenous obliteration PROCEDURE

A balloon occlusion catheter will be inserted into the venous end of the gastro-renal or gastro-caval shunt via the right femoral vein or internal jugular vein. Balloon-occluded retrograde venogram will be done to evaluate degree of retrograde filling of the gastric varices and presence of collateral veins. Any significant large collateral veins seen will be occluded with coils using microcatheter to prevent leakage of the sclerosant into the systemic circulation. Then, sclerosant agent (ethanol-amine oleate, Sodium tetradecyl sulphate, or polidocanol) will be injected into the portosystemic shunt till complete filling of the gastric varices and part of the feeding veins. Finally, the balloon left in place for 2-12 hours then gradually will be deflated when complete occlusion of blood flow of the target shunt is achieved.

Also known as: BRTO

Ballon-occluded retrograde transvenous obliteration

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1.

  PMID: 30697445 BACKGROUND

• Baig M, Ramchandani M, Puli SR. Safety and efficacy of endoscopic ultrasound-guided combination therapy for treatment of gastric varices: a systematic review and meta-analysis. Clin J Gastroenterol. 2022 Apr;15(2):310-319. doi: 10.1007/s12328-022-01600-0. Epub 2022 Feb 8.

  PMID: 35133625 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Central Study Contacts

Sara Mahrous, assistant lecturer

CONTACT

+21009605484; sarah.3000@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 15, 2022
• Study Start: August 30, 2022
• Primary Completion: August 30, 2024
• Study Completion: January 30, 2025
• Last Updated: August 16, 2022

Record last verified: 2022-08