A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding☆,☆☆
Introduction
Hemostatic treatment is essential in acute esophageal variceal bleeding, a medical emergency associated with relevant morbidity and mortality [1], [2]. Available evidence suggests that emergency sclerotherapy (EST) and vasoactive drugs have a similar efficacy and survival [3], [4]. However, EST is associated with more frequent serious adverse events [4]. By combining both therapies, the local hemostatic effect induced by endoscopic treatment on the varices is added to the portal hypotensive effect achieved with drugs. This combination is the therapy of choice currently recommended for acute variceal bleeding [5], [6], [7]. The rationale for this comes from a number of trials showing that the association of vasoactive drugs improves the efficacy of endoscopic treatment [8]. Besides, the addition of EST improves the efficacy of somatostatin (SMT) although adverse events increase as well [9].
A clear advantage may be expected using endoscopic variceal banding ligation (EVL) instead of EST, considering that fewer complications are associated with EVL [10], [11]. However, the efficacy and safety of emergency EVL to treat acute variceal bleeding are poorly defined. Several trials comparing long-term EST with EVL give separate data for acute bleeding, showing no differences [11], [12]. Only two studies, both with a small sample size, have been specifically designed to compare these endoscopic therapies in acute variceal bleeding and results were contradictory [13], [14]. Vasoactive drugs were not used in these studies. However, drugs facilitate endoscopic therapy and improve the efficacy of both EST and EVL [15], [16], [17]. The present study was performed to assess the safety and efficacy of emergency EVL in comparison with EST as endoscopic therapy added to SMT for acute esophageal variceal bleeding.
Section snippets
Patient selection and study design
From July 1999 to July 2004, all patients admitted to our hospital with hematemesis and/or melena, clinical suspicion of cirrhosis and age over 18 years were considered for inclusion. Re-randomization was only allowed if a separate bleeding episode occurred at least 45 days after the previous inclusion, but not more than twice. In all potentially eligible patients, a continuous intravenous infusion of SMT was started immediately after admission. Diagnostic endoscopy was performed within the
Results
One hundred seventy-nine episodes of esophageal variceal bleeding in 168 patients were studied, with 11 reinclusions (Fig. 1). Eighty-nine patients were randomly allocated to receive SMT plus EST and 90 to receive SMT plus EVL. Base line data were similar in both groups (Table 1). A mean of 19 ± 14 ml of ethanolamine were injected in the SMT + EST group. A mean of 8 ± 2 elastic rings were placed in the SMT + EVL group.
Discussion
The present study suggests that EVL has substantial advantages over EST as emergency endoscopic therapy added to SMT for acute esophageal variceal bleeding. The current results show that EVL is safer than EST even when such endoscopic treatments are used on an emergency basis, in association with SMT. EVL is a mechanical method of obliterating varices which may avoid the systemic effects associated with EST, and since the amount of tissue ligated is limited it should also result in fewer
Acknowledgements
We thank the nursing and medical staff of the Gastrointestinal Bleeding Unit and of Semi-Critics Unit of the Hospital de la Santa Creu i Sant Pau for their cooperation in this study.
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This study has been supported in part by a grant from the Fundació Investigació Sant Pau and by a grant from the Instituto de Salud Carlos III (CO3/02).
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The authors who have taken part in this study declared that they have no relationship with the manufactures of the drugs involved either in the past or present and did not receive funding from the manufacturers to carry out their research.