Combined ligation and sclerotherapy versus ligation alone for eradication of bleeding esophageal varices: a randomized and prospective trial.

BACKGROUND AND STUDY AIMS: A number of trials have been reported in which a combination of ligation and sclerotherapy was compared with ligation alone, or with sclerotherapy alone. The present trial was carried out to assess whether the combined therapy might achieve more rapid eradication of bleeding esophageal varices. PATIENTS AND METHODS: One hundred and three patients with either active bleeding or stigma of recent bleeding from esophageal varices were randomly assigned to receive ligation plus sclerotherapy, or ligation alone. Ligation was performed with the technique introduced by Stiegmann. Sclerotherapy was carried out using low-volume (1 ml) 1% aethoxysclerol, which was injected into varices proximal to each ligature. Further treatment sessions were held seven days later, and then at two-week intervals, until eradication of the varices was achieved. Endoscopic follow-up examinations were carried out at three-month intervals, or immediately if there was any recurrent bleeding. The mean follow-up period was 14 months.
RESULTS: There were no significant differences between the groups of patients compared with regard to the number of sessions required to eradicate the varices (2.4 +/- 0.7 in the combined group, and 2.3 +/- 0.7 in the ligation group; p>0.05). No significant differences were found between the groups with regard to recurrent bleeding (Fp = 2.882; p > 0.05). Three cases of recurrent bleeding (6%) from treatment-induced ulcers and two cases of recurrent bleeding (4%) from duodenal ulcers were observed with the combined therapy and ligation, respectively. No significant differences in the mortality were found between the groups (Fp = 1.145; p>0.05). Two percent of patients in the ligation group died due to bacterial peritonitis.
CONCLUSION: Since ligation combined with low-volume sclerotherapy did not reduce the time required for variceal eradication, it can be concluded that the combined therapy is not superior to ligation alone. This mode of endoscopic therapy for the treatment of bleeding esophageal varices is therefore not recommended.

RCT Entities:   Population Interventions Outcomes