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

National Science Council, Taiwan

Status and phase: Unknown; Phase 3

Conditions: Rebleeding From Gastric Varices; Ulcer, on Gastric Varices

Treatments: Drug: Histoacryl; Drug: Thrombin

Study type: Interventional

Funder types: Other

Identifiers

NCT01717612

Thrombin study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Histoacryl group

Active Comparator group

Description:

the injected agents consisted of n-butyl-2-cyanoacrylate (Histoacryl; B.Braun, Melsungen AG, Germany) 0.5ml mixed with 1.5 ml Lipiodol ultra-fluide (Guerbet, Bois Cedex, France). The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.

Treatment:

Drug: Histoacryl

thrombin group

Experimental group

Description:

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)

Treatment:

Drug: Thrombin