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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBCA-lipiodol | Active Comparator | Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices |
|
| NBCA-lauromacrogol | Experimental | Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol | Drug | endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| incidence rate of ulcer formation | The patients will be assessed if ulceration is formed on the site of the injection when they have gastroscopy review in 2 months after the initial endoscopic treatment. | 2 months after the initial endoscopic treatment |
| eradication rate of gastric varices |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyao Chen, MD | Zhongshan Hospital, Shanghai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 0086200032 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2016 | |
| Reset | Feb 11, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2016 | Feb 11, 2016 |
| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| D000077423 | Polidocanol |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 |
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| Lauromacrogol | Drug | endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices |
|
Patients will be evaluated if gastric varices are eradicated when they have gastroscopy review in 2 months after the initial endoscopic treatment. |
| 2 months after the initial endoscopic treatment |
| incidence rate of complications | Participants will be followed for up to 6 months starting from the date of enrollment.Complications associated with endoscopic treatments include transient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain. | 6 months |
| Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |