A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding

Rebleeding From Gastric Varices Clinical Trial

Official title:

A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01717612
• Other study ID #: Thrombin study
• Status: Recruiting
• Phase: Phase 3
• First received: October 26, 2012
• Last updated: November 2, 2012
• Start date: October 2012

Study information

• Verified date: November 2012
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.

Description:

Previous studies have proven that the use of cyanoacrylate glue injection was superior to EIS or EVL in arresting acute gastric variceal bleeding. Endoscopic obturation with glue injection has gained worldwide popularity except the United States. The hemostatic rates of glue injection ranged from 87% to 100%, with rebleeding rates about 7% to 71%.

Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported. The mechanism of hemostasis induced by thrombin is through the conversion of fibrinogen to fibrin and enhancement of platelets aggregation. This trial aimed to compare the relative efficacy and safety between histoacryl injection and thrombin injection in the prevention of gastric variceal rebleeding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1.The etiology of portal hypertension is cirrhosis. 2.Age ranges between 20-80 y/o. 3.Patients presenting with history of gastric variceal bleeding or acute gastric variceal bleeding proven by emergency endoscopy

Exclusion Criteria:

• 1) association with severe systemic illness, such as sepsis, CVA, COPD, advanced carcinoma, hepatocellular carcinoma (Barcelona Club Liver Cancer class C or D) 2) presence of massive ascites 3), serum creatinine >3mg/dl, hepatic encephalopathy > stage II, 4) serum bilirubin > 10mg/dl 5) life expectancy less than 24 hours 6) Child-Pugh's scores > 13 7) pregnancy 8) has ulcers on gastric varices 9) Uncooperative

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Rebleeding From Gastric Varices
• Ulcer, on Gastric Varices

Intervention

Drug:
• Thrombin
Among the thrombin group, the injection site was also aimed at the bleeding varices or varices with red color signs or at the most prominent varices. The injected agents consisted of lyophilized human Thrombin in calcium chloride solution containing thrombin 500IU/ml). (Floseal, Baxter Healthcare Corporation, CA, Hayward, USA)
• Histoacryl
The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.

Locations

Country	Name	City	State
Taiwan	E-DA Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
National Science Council, Taiwan	E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer on gastric varices	ulcer crater or ulcer with bleeding from gastric varices	1 month after therapy	Yes
Secondary	rebleeding	rebleeding from gastric varices	6 weeks	No