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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Variceal Bleeding
• Intervention / Treatment: Procedure: Cyanoacrylate; Procedure: Cyanoacrylate

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
• Enrollment (Actual): 105
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; Procedure: Cyanoacrylate; Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot
Experimental: B; Double doses cyanoacrylate in one shot	Procedure: Cyanoacrylate; Cyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot; Procedure: Cyanoacrylate; Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rebleeding	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival	2 year

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Estimate): October 6, 2010
• Last Update Submitted That Met QC Criteria: October 4, 2010
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: gastric variceal bleeding; survival; complication; rebleeding; cyanoacrylate; acute gastric variceal bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 95DHA0100359