Randomized trial of ligation versus combined ligation and sclerotherapy for bleeding esophageal varices

Background: Endoscopic band ligation combined with sclerotherapy has been p ostulated to be superior to ligation alone for the treatment of esophageal variceal bleeding. Methods: A randomized trial of ligation versus combined ligation and sclero therapy was designed to determine whether combined therapy results in faste r eradication of varices compared to ligation alone. Sixty patients were ra ndomized to undergo band ligation or ligation combined with injection of 1 to 2 mt of polidocanol (1%) into each variceal column immediately proximal to the previously placed bands. Therapy was repeated at 1- or 2-week interv als until variceal eradication was achieved. Follow-up endoscopy was perfor med at 3 months and then at 6-month intervals. Results: The demographic and clinical characteristics of the 31 patients wh o underwent ligation were similar to those of the 29 who received combined treatment. Sixty percent of the patients had cirrhosis due to viral hepatit is. No significant differences were found between the combined and ligation alone groups in arresting active bleeding [9 of 9 (100%) vs. 6 of 7 (86%)] , units of blood transfusion (3 +/- 0.8 vs. 2 +/- 0.6), number of sessions required to eradicate varices (3.8 +/- 0.5 vs. 3.6 +/- 0.4), treatment fail ure [2 (17%) vs. 4 (14%)], esophageal varice recurrence [6 (21.%) vs. 2 (6% )], gastric varices formation [4 (14%) vs. 1 (3%)], stricture [1 (3%) vs. 0 (0%)], recurrent bleeding [5 (17%) vs. 7 (23%)], other complications [10 ( 34%) vs. 9 (29%)], or death [3 (10%) vs. 7 (23%)] during a follow-up period of up to 36 months. Conclusions: Combined ligation and sclerotherapy does not reduce the number of endoscopic treatment sessions required for variceal eradication and off ers no benefit over ligation alone. Because of the lack of benefit, the add ed procedure time, and the cost, we do not advocate combination therapy, an d ligation alone remains the best endoscopic treatment.