Clinical trial NCT01717612: A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding
Official title: A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ulcer, on Gastric Varices
Rebleeding From Gastric Varices
Keywords: gastric varices, thrombin, histoacryl
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: E-DA Hospital
First posted: 2012-10-30
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ulcer on gastric varices
timeFrame: 1 month after therapy
Secondary outcomes:
measure: rebleeding
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
Study officials:
References:
citation: Lo GH, Lin CW, Tai CM, Perng DS, Chen IL, Yeh JH, Lin HC. A prospective, randomized trial of thrombin versus cyanoacrylate injection in the control of acute gastric variceal hemorrhage. Endoscopy. 2020 Jul;52(7):548-555. doi: 10.1055/a-1127-3170. Epub 2020 Apr 14.