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

This study has been completed.
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00735358
First received: August 12, 2008
Last updated: October 4, 2010
Last verified: August 2008
  Purpose

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 Intervention Phase
Gastric Variceal Bleeding
Procedure: Cyanoacrylate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Rebleeding [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: September 2005
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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.

No Contacts or Locations Provided
  More Information

No publications provided by Taipei Veterans General Hospital, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chan Cho-Yu, M.D, / excutive officer of IRB of Taipei VGH, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00735358     History of Changes
Other Study ID Numbers: 95DHA0100359
Study First Received: August 12, 2008
Last Updated: October 4, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
gastric variceal bleeding
cyanoacrylate
rebleeding
complication
survival
acute gastric variceal bleeding

ClinicalTrials.gov processed this record on September 22, 2014