Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
Primary Purpose
Gastric Varix
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection
Ballon-occluded retrograde transvenous obliteration
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Varix
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EUS-guided coil embolization combined with endoscopic cyanoacrylate injection
Ballon-occluded retrograde transvenous obliteration
Arm Description
Outcomes
Primary Outcome Measures
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)
Time of procedure
Time of the whole procedure of EUS and BRTO
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05500625
Brief Title
Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
Official Title
Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2022 (Anticipated)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varix
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-guided coil embolization combined with endoscopic cyanoacrylate injection
Arm Type
Experimental
Arm Title
Ballon-occluded retrograde transvenous obliteration
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection
Other Intervention Name(s)
EUS-guided coil embolization combined with endoscopic cyanoacrylate injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ballon-occluded retrograde transvenous obliteration
Other Intervention Name(s)
BRTO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastric varices bleeding control
Description
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)
Time Frame
7 days
Title
Time of procedure
Description
Time of the whole procedure of EUS and BRTO
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Mahrous, assistant lecturer
Phone
+21009605484
Email
sarah.3000@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
30697445
Citation
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.
Results Reference
background
PubMed Identifier
35133625
Citation
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.
Results Reference
background
Links:
URL
https://assets.researchsquare.com/files/rs-1523109/v1/6a9e1d74-f733-4ec1-a34e-0468336bf04b.pdf?c=1656600832
Description
Endoscopic Ultrasound Guided Therapy of Gastric Varices: Initial Experience in the Arab World (with video)
URL
https://assets.researchsquare.com/files/rs-1546433/v1/a07860c1-8ed9-46a2-9157-bbcdc208ec77.pdf?c=1651076535
Description
Endoscopic variceal obturation and retrograde transvenous obliteration for acute gastric cardiofundal variceal bleeding
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Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
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