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

NCT ID: NCT00292331

Last Updated: 2006-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Gastric Variceal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cyanoacrylate injection to treat gastric variceal hemorrhage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Ming-Chih Hou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Ming-Chih Hou, M.D.

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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VGH-88-B251

Identifier Type: -

Identifier Source: org_study_id