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Sponsor study identifier
interventional
70
0 countries
N/A
Study Start
August 30, 2022
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Primary Completion
August 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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January 30, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2022
Actual (reported)August 15, 2022
Actual (reported)August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordBoregowda 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.
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.
First Submitted
July 29, 2022
First Posted
August 15, 2022
Study Start
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 30, 2024
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.
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Study Completion
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 16, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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