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

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ClinicalTrials.gov Identifier: NCT00292331
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : February 15, 2006
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan

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).

Condition or disease Intervention/treatment Phase
Gastric Variceal Hemorrhage Procedure: cyanoacrylate injection to treat gastric variceal hemorrhage Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Endoscopic Treatment of Acute Gastric Variceal Hemorrhage: N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources




Primary Outcome Measures :
  1. Comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute gastric variceal hemorrhage (GVH) in liver cirrhotic patients


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292331


Locations
Taiwan
Ming-Chih Hou, M.D.
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Ming-Chih Hou, M.D. Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier: NCT00292331     History of Changes
Other Study ID Numbers: VGH-88-B251
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: February 15, 2006
Last Verified: February 2006

Keywords provided by Taipei Veterans General Hospital, Taiwan:
gastric varices
liver cirrhosis
hepatocelluar carcinoma
rebleeding
long-term

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes