Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
Primary Purpose
Gastric Variceal Bleeding
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cyanoacrylate
Cyanoacrylate
Sponsored by

About this trial
This is an interventional treatment trial for Gastric Variceal Bleeding focused on measuring gastric variceal bleeding, cyanoacrylate, rebleeding, complication, survival, acute gastric variceal bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients with liver cirrhosis and/or hepatoma
- Aged 18 to 80, who had endoscopy-proven acute GVB
- Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena
- Endoscopic signs of active bleeding from the GV
- Adherent blood clots, white nipple signs, or erosions on the GV
- The presence of distinct large GV with red-color signs and absence of EV and other bleeding sources
- Who or their legally authorized representatives gave informed consent
Exclusion Criteria:
- Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB
- Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Single dose cyanoacrylate in one shot
Double doses cyanoacrylate in one shot
Outcomes
Primary Outcome Measures
Rebleeding
Secondary Outcome Measures
Survival
Full Information
NCT ID
NCT00735358
First Posted
August 12, 2008
Last Updated
October 4, 2010
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00735358
Brief Title
Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better hemostasis.
Detailed Description
Although outcome of variceal hemorrhage has been improved in the last two decades, variceal hemorrhage is still the most serious complication of portal hypertension and chronic liver disease. Occurrence of gastric varices (GV) rupture is less often than esophageal varices (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than EV hemorrhage. Facing these challenges, there is no consensus on the best treatment of GV hemorrhage and therefore it is mainly empirical. Endoscopic treatment is an alternative in the management of GVH. Injection sclerotherapy has been applied to arrest GV hemorrhage but it is associated with a high rebleeding rate (50~90%) and thus is regarded as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation for EV hemorrhage has been documented, however, endoscopic variceal ligation for GVH is not as promising because of its high rebleeding rate around 50%. Endoscopic injection of N-butyl-2-cyanoacrylate, a so-called "tissue glue", was more effective for GV hemorrhage than other sclerosants and endoscopic ligation, however, its rebleeding rate is still high around 30~50%. The theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately. Each injection of tissue glue in conventional use was usually prepared by a mixture of 0.5 ml cyanoacrylate and 0.5 ml Lipiodol. Therefore, we hypothesized that double dose cyanoacrylate (1 ml cyanoacrylate mixed with 1 ml Lipiodal) may obliterate the varices in further distance and broader area and that may achieve more effective hemostatic results than conventional dose. Therefore we designed a randomized trial to test the hypothesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Variceal Bleeding
Keywords
gastric variceal bleeding, cyanoacrylate, rebleeding, complication, survival, acute gastric variceal bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Single dose cyanoacrylate in one shot
Arm Title
B
Arm Type
Experimental
Arm Description
Double doses cyanoacrylate in one shot
Intervention Type
Procedure
Intervention Name(s)
Cyanoacrylate
Intervention Description
Cyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot
Intervention Type
Procedure
Intervention Name(s)
Cyanoacrylate
Intervention Description
Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot
Primary Outcome Measure Information:
Title
Rebleeding
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Survival
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with liver cirrhosis and/or hepatoma
Aged 18 to 80, who had endoscopy-proven acute GVB
Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena
Endoscopic signs of active bleeding from the GV
Adherent blood clots, white nipple signs, or erosions on the GV
The presence of distinct large GV with red-color signs and absence of EV and other bleeding sources
Who or their legally authorized representatives gave informed consent
Exclusion Criteria:
Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB
Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.
12. IPD Sharing Statement
Citations:
PubMed Identifier
19559427
Citation
Hou MC, Lin HC, Lee HS, Liao WC, Lee FY, Lee SD. A randomized trial of endoscopic cyanoacrylate injection for acute gastric variceal bleeding: 0.5 mL versus 1.0 mL. Gastrointest Endosc. 2009 Oct;70(4):668-75. doi: 10.1016/j.gie.2009.02.005. Epub 2009 Jun 25.
Results Reference
derived
Learn more about this trial
Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
We'll reach out to this number within 24 hrs