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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by National Science Council, Taiwan
Sponsor:
Collaborator:
E-DA Hospital
Information provided by (Responsible Party):
Gin-Ho Lo, E-DA Hospital
ClinicalTrials.gov Identifier:
NCT01717612
First received: October 26, 2012
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Ulcer, on Gastric Varices
Rebleeding From Gastric Varices
Drug: Thrombin
Drug: Histoacryl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding

Resource links provided by NLM:


Further study details as provided by National Science Council, Taiwan:

Primary Outcome Measures:
  • Ulcer on gastric varices [ Time Frame: 1 month after therapy ] [ Designated as safety issue: Yes ]
    ulcer crater or ulcer with bleeding from gastric varices


Secondary Outcome Measures:
  • rebleeding [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    rebleeding from gastric varices


Estimated Enrollment: 62
Study Start Date: October 2012
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Histoacryl group
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.
Drug: Histoacryl
The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.
Other Name: n-butyl-2-cyanoacrylate
Experimental: thrombin group
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)
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)

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717612

Locations
Taiwan
E-DA Hospital Recruiting
Kaohsiung, Taiwan, 824
Contact: Gin-Ho Lo, M.D    886-7-6150011 ext 1629    ghlo@kimo.com   
Principal Investigator: Gin-Ho Lo, M.D.         
Sponsors and Collaborators
National Science Council, Taiwan
E-DA Hospital
  More Information

No publications provided

Responsible Party: Gin-Ho Lo, Vice Superintendent, E-DA Hospital, E-DA Hospital
ClinicalTrials.gov Identifier: NCT01717612     History of Changes
Other Study ID Numbers: Thrombin study
Study First Received: October 26, 2012
Last Updated: November 2, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Science Council, Taiwan:
gastric varices, thrombin, histoacryl

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Liver Diseases
Thrombin
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014