NCT01717612

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

3.5 years

First QC Date

October 26, 2012

Last Update Submit

November 2, 2012

Conditions

Ulcer, on Gastric VaricesRebleeding From Gastric Varices

Keywords

gastric varices, thrombin, histoacryl

Outcome Measures

Primary Outcomes (1)

  • Ulcer on gastric varices

    ulcer crater or ulcer with bleeding from gastric varices

    1 month after therapy

Secondary Outcomes (1)

  • rebleeding

    6 weeks

Study Arms (2)

Histoacryl group

ACTIVE COMPARATOR

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

thrombin group

EXPERIMENTAL

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

Interventions

ThrombinDRUG

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)

thrombin group
HistoacrylDRUG

The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.

Also known as: n-butyl-2-cyanoacrylate
Histoacryl group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-DA Hospital

Kaohsiung City, 824, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32289853DERIVED

MeSH Terms

Conditions

UlcerEsophageal and Gastric Varices

Interventions

ThrombinEnbucrilate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological FactorsCyanoacrylatesAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Superintendent, E-DA Hospital

Study Record Dates

First Submitted

October 26, 2012

First Posted

October 30, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2016

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

TW(1)