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N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage

Primary Purpose

Gastric Variceal Hemorrhage

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
cyanoacrylate injection to treat gastric variceal hemorrhage
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Variceal Hemorrhage focused on measuring gastric varices, liver cirrhosis, hepatocelluar carcinoma, rebleeding, long-term

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: * Patients who were aged between 18 and 80 years and had endoscopy-proven acute gastric variceal hemorrhage (GVH) Exclusion Criteria: Cases with concomitant large GV and large EV, but without stigmata of recent bleeding Cases had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt for GVH Cases had a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or nonhepatic malignancy

Sites / Locations

  • Ming-Chih Hou, M.D.

Outcomes

Primary Outcome Measures

Comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute gastric variceal hemorrhage (GVH) in liver cirrhotic patients

Secondary Outcome Measures

Full Information

First Posted
February 14, 2006
Last Updated
February 14, 2006
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00292331
Brief Title
N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage
Official Title
A Randomized Trial of Endoscopic Treatment of Acute Gastric Variceal Hemorrhage: N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
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Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was to test the hypothesis by comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC).
Detailed Description
Gastric variceal hemorrhage (GVH) has a poorer prognosis than esophageal variceal hemorrhage. However, data on its optimal treatment are limited. We designed a prospective study to compare the efficacy of endoscopic band ligation (GVL) and endoscopic N-butyl-2-cyanoacrylate injection (GVO). Liver cirrhotic patients with or without concomitant hepatocelluar carcinoma (HCC) and patients presenting with acute GVH were randomized into two treatment groups. Forty-eight patients received GVL, and another 49 patients received GVO. Both treatments were equally successful in controlling active bleeding (14/15 vs. 14/15, P = 1.000). More of the patients who underwent GVL had GV rebleeding (GVL vs. GVO, 21/48 vs. 11/49; P = .044). The 2-year and 3-year cumulative rate of GV rebleeding were 63.1% (95% confidence interval [CI], 44.5%-81.7%), 72.3% (95% CI, 51.3%-93.3%) for GVL and 26.8% (95% CI, 12.5%-41.1%), 26.8% (95% CI, 12.5%-41.1%) for GVO; P = .0143, log-rank test. The rebleeding risk of GVL sustained throughout the entire follow-up period. Multivariate Cox regression indicated that concomitance with HCC (relative hazard: 2.453, 95% CI: 1.036-5.806, P = .041) and the treatment method (GVL vs. GVO, relative hazard: 2.660, 95% CI: 1.167-6.061, P = .020) were independent factors predictive of GV rebleeding. There was no difference in survival between the two groups. Severe complications due to these two treatments were rare. In conclusion, the efficacy of GVL to control active GVH appears to have no difference with GVO, but GVO is associated with a lower GV rebleeding rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Variceal Hemorrhage
Keywords
gastric varices, liver cirrhosis, hepatocelluar carcinoma, rebleeding, long-term

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
cyanoacrylate injection to treat gastric variceal hemorrhage
Primary Outcome Measure Information:
Title
Comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute gastric variceal hemorrhage (GVH) in liver cirrhotic patients

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 who were aged between 18 and 80 years and had endoscopy-proven acute gastric variceal hemorrhage (GVH) Exclusion Criteria: Cases with concomitant large GV and large EV, but without stigmata of recent bleeding Cases had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt for GVH Cases had a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or nonhepatic malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Hou, M.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ming-Chih Hou, M.D.
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage

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