Efficacy and Safety of EUS-Guided Therapy Versus BRTO for Gastric Varices With Shunt

Study Overview
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Brief Summary
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This study is a retrospective, multi-center and observational clinical study. Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The fifth medical center of PLA General Hospital, Zhongshan Hospital, Fudan University, Shanghai, Nanjing Drum Tower Hospital affiliated Nanjing University Medical School and Xiangyang Central Hospital will participate in the study. Investigators would like to provide evidence-based medical evidence by evaluating and comparing the efficacy and safety of endoscopic ultrasound (EUS)-guided coil embolization combined with endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous obliteration (BRTO) in the treatment of gastric varices (GV) with spontaneous portosystemic shunt (SPSS). Between January 2014 and December 2020, patients with GV secondary to portal hypertension admitted to a tertiary medical center, are enrolled consecutively according to the following criteria: (1) age≥18 years; (2)endoscopic examination confirms the presence of GV; (3) CTA of the portal system and EUS revealed the presence of SPSS, the diameter was between 5 mm to 15 mm; (4) treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO. Exclusion criteria are as follows: (1)malignant tumors; (2) hepatic encephalopathy, hepatorenal syndrome or multiple organ failure; (3) previously received esophagus or stomach surgery; (4) pregnant. Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until the progress of the disease or the end of the study. And rebleeding, ectopic embolism, survival, and sequential treatment will be recorded during the follow-up period. The primary endpoint are five-day rebleeding rate and six-week mortality rate. The secondary endpoint are: technical success rate, incidence of ectopic embolism, eradication of GV, one-year rebleeding rate, one-year mortality rate, and cost-effectiveness ratio. All data and information use SPSS statistical software to complete all statistical analysis.

Detailed Description
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Because the efficacy and safety of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection and BRTO in the treatment of GV with SPSS have different conclusions in different studies. Investigators based on that the five-day rebleeding rate of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection is 7%, BRTO is 10%. The number of people in the two groups are equal, significant level (α) is 0.05, and the test power is 0.8. Each group requires 35 patients. Because of the 10% loss to follow-up, the sample capacity is 39.

Official Title
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Efficacy and Safety of EUS-Guided Coil Embolization Combined With Endoscopic Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration for Gastric Varices With High-risk Ectopic Embolism

Conditions
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Portal Hypertension, Liver Cirrhosis, Gastric Varix, Portosystemic Shunt

Intervention / Treatment
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* Procedure: EUS-guided coil embolization combined with endoscopic cyanoacrylate injection
* Procedure: balloon-occluded retrograde transvenous obliteration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≥18 years endoscopic examination confirmed the presence of gastric varices CTA of the portal system and EUS revealed the presence of spontaneous portosystemic shunt (SPSS) that the diameter was between 5 mm to 15 mm treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO Exclusion Criteria: malignant tumors hepatic encephalopathy, hepatorenal syndrome or multiple organ failure previously received esophagus or stomach surgery pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EUS group<br>Patients who received EUS-guided coil embolization combined with endoscopic cyanoacrylate injection | Procedure: EUS-guided coil embolization combined with endoscopic cyanoacrylate injection<br>* (1) Standard diagnostic endoscopy was first performed. Fundal varices were assessed using the classification of Sarin's. (2) intraluminal water filling of the gastric fundus to 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. (3) Punctured the gastric fundal variceal vein at the lower esophagus near the cardia and placed the coil into the shunt and immediately injected with sclerosant and cyanoacrylate under the guidance of EUS. (4) Sclerosant and cyanoacrylate were injected into the gastric fundal varices by a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. (5) After the injection, use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect.<br>|
| BRTO group<br>Patients who received balloon-occluded retrograde transvenous obliteration (BRTO) | Procedure: balloon-occluded retrograde transvenous obliteration<br>* (1)A balloon occlusive catheter was inserted into the shunt via the right femoral vein. (2)Investigators performed angiography to evaluate the size and location of GV and the shunt during balloon occlusion. Shunt was occluded by Fogarty balloon. The diameter of the balloon was chosen according to the diameter of shunt. (3)Then investigators injected sclerosant into the portosystemic shunt. (4)Finally, the balloon left in place for 24 hours was gradually deflated when complete occlusion of blood flow of the target shunt was achieved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| five-day rebleeding rate | Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible. | 5 days after treatment | 
| six-week mortality rate | Patients died in six weeks after treatment due to all causes. | 6 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success rate | The coil or balloon was successfully employed and occluded the shunt | in the procedure of treatment | 
| incidence of ectopic embolism | Patients occurred ectopic embolism after treatment confirmed by CTA, ultrasound, etc, with or without clinical manifestation | up to 3 years after treatment | 
| eradication of gastric varices | Eradication of the gastric varices is defined as absence of gastric varices on endoscopy or absence of blood flow of gastric varices on endoscopic ultrasound | 1 year after treatment | 
| one-year rebleeding rate | Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible | 1 year after treatment | 
| one-year mortality rate | Patients died in one year after treatment due to all causes. | 1 year after treatment |