Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00735358
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : October 6, 2010
Information provided by:
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Gastric Variceal Bleeding Procedure: Cyanoacrylate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: A
Single dose cyanoacrylate in one shot
Procedure: Cyanoacrylate
Cyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot

Experimental: B
Double doses cyanoacrylate in one shot
Procedure: Cyanoacrylate
Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot

Primary Outcome Measures :
  1. Rebleeding [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chan Cho-Yu, M.D, / excutive officer of IRB of Taipei VGH, Taipei Veterans General Hospital Identifier: NCT00735358     History of Changes
Other Study ID Numbers: 95DHA0100359
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: October 6, 2010
Last Verified: August 2008

Keywords provided by Taipei Veterans General Hospital, Taiwan:
gastric variceal bleeding
acute gastric variceal bleeding

Additional relevant MeSH terms:
Pathologic Processes