Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: NBCA-lipiodol Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices |
Drug: Lipiodol
endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
|
| Experimental: NBCA-lauromacrogol Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices |
Drug: Lauromacrogol
endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices
|
Outcome Measures
Primary Outcome Measures
- bleeding rate of the puncture site [time period since the beginning of the injection, until up to 24 hours after the procedure]
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.
Secondary Outcome Measures
- Rebleeding rate after endoscopic treatment [6 months from the date of enrollment]
Patients were followed up for 6 months to see if they experience relapse of bleeding, presenting melena, haematemesis or both.
Other Outcome Measures
- incidence rate of ulcer formation [2 months after the initial endoscopic treatment]
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.
- eradication rate of gastric varices [2 months after the initial endoscopic treatment]
Patients will be evaluated if gastric varices are eradicated when they have gastroscopy review in 2 months after the initial endoscopic treatment.
- incidence rate of complications [6 months]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital | Shanghai | Shanghai | China | 0086200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Director: Shiyao Chen, MD, Zhongshan Hospital, Shanghai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- chen2013