Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02672319 |
| Other study ID # |
EUS Glue Study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2014 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Bleeding from gastroesophageal varices is one of the major complications of cirrhosis. After
successful treatment of the acute bleeding episode, patients who do not receive follow-up
treatment to prevent rebleeding were reported to have a rebleeding rate of 60% within 1- 2
years. The presence of liver cancer and/or portal vein thrombosis has been associated with
recurrent variceal bleeding. In a study of liver cancer patients in Hong Kong, 7.9% of
patients developed at least 1 episode of variceal bleeding over the course of liver cancer.
In patients with portal hypertension from cirrhosis, current guidelines recommend
non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial
bleeding, and either cyanoacrylate injection for variceal obturation or transjugular
intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is
unclear whether the above strategies will have the same clinical effect for patients with
liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding.
Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection
for variceal obturation has been described. In a study of patients with gastric variceal
bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all
patients and 96% of the gastric varices remained obliterated during the follow-up period. To
date, there has been no dedicated study to evaluate the role of EUS guided glue injection for
prevention of future bleeding in patients at high risk for recurrent variceal bleeding such
as those with liver cancer or portal vein thrombosis.
The investigators propose this study to evaluate the feasibility and safety of EUS guided
glue injection for follow-up variceal treatment in patients at high risk for recurrent
variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.
Description:
Gastroesophageal variceal bleeding is one of the major complications of cirrhosis and occurs
at a rate of 5 to 15% per year. 50% of patients with cirrhosis develop variceal bleeding
during their lifetime. Large varix size, presence of red wale signs on endoscopy, and
decompensated cirrhosis are predictors of variceal hemorrhage. Current first-line management
of acute variceal bleeding includes a combination of vasoactive drug, endoscopic therapy and
antibiotic prophylaxis. Despite advances in the management of acute variceal bleeding, the
6-week mortality remains significant at 15 - 20% per episode of variceal bleeding.
In patients who survive the acute variceal bleeding episode but without secondary
prophylaxis, the median rebleeding rate is about 60% within 1- 2 years of the index bleeding
with a mortality of 33%. The presence of hepatocellular carcinoma (HCC) and/or portal vein
thrombosis (PVT) have been associated with recurrent variceal bleeding and worse outcome. In
a retrospective study of 2928 HCC patients in Hong Kong, 7.9% of the patients developed at
least 1 episode of variceal bleeding over the course of HCC. In cirrhotic patients with PVT
but without HCC, variceal bleeding is not an uncommon complication.
In patients with portal hypertension from cirrhosis, current guidelines recommend
non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial
bleeding, and either cyanoacrylate injection for variceal obturation or transjugular
intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is
unclear whether the above strategies will have the same clinical effect for patients with
liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding.
Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection
for variceal obturation has been described. In a study of patients with gastric variceal
bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all
patients and 96% of the gastric varices remained obliterated during the follow-up period. To
date, there has been no dedicated study to evaluate the role of EUS guided glue injection for
prevention of future bleeding in patients at high risk for recurrent variceal bleeding such
as those with liver cancer or portal vein thrombosis.
The investigators propose this study to evaluate the feasibility and safety of EUS guided
glue injection for follow-up variceal treatment in patients at high risk for recurrent
variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.
