Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02672319
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2015-09-09
Brief Title:
EUS-guided Glue Injection for Varices Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Endoscopic Ultrasound EUS Guided Cyanoacrylate Injection for Variceal Obturation as Secondary Prophylaxis for Patients at High Risk for Recurrent Gastroesophageal Variceal Bleeding
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor portal vein thrombosis has been associated with recurrent variceal bleeding In a study of liver cancer patients in Hong Kong 79 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 andor 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 andor portal vein thrombosis
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 andor 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 andor portal vein thrombosis
Detailed 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 andor 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 79 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 andor 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 andor portal vein thrombosis
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 andor 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 79 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 andor 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 andor portal vein thrombosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None