Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices

Study Overview
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Brief Summary
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The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Detailed Description
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Gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. When a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. However, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. We conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Official Title
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A Randomized Study to Compare Effect of Endoscopic Injection of a Mixture of Cyanoacrylate and Lipiodol Versus Cyanoacrylate and Lauromacrogol in Gastric Varices

Conditions
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Gastric Varices, Portal Hypertension

Intervention / Treatment
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* Drug: Lipiodol
* Drug: Lauromacrogol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis. The age of the patients range from 18 to 80 years old. Exclusion Criteria: Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy. Patients who have abnormal portosystemic shunt according to the imaging results. Patients who have no previous upper gastrointestinal bleeding history. Patients who have multiple endoscopic treatments for esophagogastric varices before.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NBCA-lipiodol<br>Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices | Drug: Lipiodol<br>* endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices<br>|
| Experimental: NBCA-lauromacrogol<br>Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices | Drug: Lauromacrogol<br>* endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding rate of the puncture site | We tend to observe the immediate puncture site bleed on the injection of cyanoacrylate and lipiodol or lauromacrogol and withdrawal of needle catheter during endoscopic treatment of gastric varices. | time period since the beginning of the injection, until up to 24 hours after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate after endoscopic treatment | Patients were followed up for 6 months to see if they experience relapse of bleeding, presenting melena, haematemesis or both. | 6 months from the date of enrollment |