Abstract
Background and purpose
Elective esophageal variceal ligation (EVL) is performed to decrease the risk of variceal hemorrhage. EVL is associated with adverse effects, including post-ligated bleeding, chest pain, and dysphagia. Proton pump inhibitors (PPIs) are the most potent pharmacological agents for inhibition of gastric acid secretion. However, the long-term effect of PPIs after EVL remains unclear. The aim of this study was to assess the efficacy of rabeprazole, a PPI, after variceal eradication by EVL.
Methods
We performed a randomized, controlled trial in Kitasato University East Hospital. The primary endpoint was treatment failure, defined as variceal hemorrhage or severe medical complications. Between July 2007 and September 2010, 43 patients were randomized into this study and followed up until September 2010.
Results
Twenty-one patients in the rabeprazole arm received 10 mg rabeprazole daily after EVL, and 22 patients in the control received no antisecretory treatment from the same stage. Baseline characteristics did not differ between the groups (median Child-Pugh score, 6; median age, 62 years; median follow-up, 18.7 months). The trial was stopped early after an interim analysis showed that the risk of bleeding and failure of rabeprazole treatment was lower than that of no antisecretory treatment with the log-rank test showing a significant difference between the groups (P = 0.007) and a hazard ratio of 0.098 [95% confidence interval, 0.012–0.79 (P = 0.029)].
Conclusions
Long-term administration of PPIs reduced the risk of treatment failure after EVL. Acid suppression therapy should also be considered as a treatment option after EVL.
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Abbreviations
- EVL:
-
Endoscopic variceal ligation
- PPI:
-
Proton pump inhibitor
- HVPG:
-
Hepatic venous pressure gradient
- ARB:
-
Angiotensin II type 1 receptor blocker
- HCC:
-
Hepatocellular carcinoma
- ITT:
-
Intention-to-treat
- SD:
-
Standard deviation
- HR:
-
Hazard ratio
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Acknowledgments
The authors thank the radiologists of Kitasato University East Hospital for their technical assistance. We also thank Robert E. Brandt (Founder, CEO, and CME, MedEd, Japan) for editing the manuscript.
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The trial described in this work has been registered under the following trial number: UMIN000003913.
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Hidaka, H., Nakazawa, T., Wang, G. et al. Long-term administration of PPI reduces treatment failures after esophageal variceal band ligation: a randomized, controlled trial. J Gastroenterol 47, 118–126 (2012). https://doi.org/10.1007/s00535-011-0472-0
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DOI: https://doi.org/10.1007/s00535-011-0472-0