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

Background: Endoscopic band ligation combined with sclerotherapy has been postulated to be superior to ligation alone for the treatment of esophageal variceal bleeding. Methods: A randomized trial of ligation versus combined ligation and sclerotherapy was designed to determine whether combined therapy results in faster eradication of varices compared to ligation alone. Sixty patients were randomized 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 intervals until variceal eradication was achieved. Follow-up endoscopy was performed at 3 months and then at 6-month intervals. Results: The demographic and clinical characteristics of the 31 patients who underwent ligation were similar to those of the 29 who received combined treatment. Sixty percent of the patients had cirrhosis due to viral hepatitis. 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 failure [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 offers no benefit over ligation alone. Because of the lack of benefit, the added procedure time, and the cost, we do not advocate combination therapy, and ligation alone remains the best endoscopic treatment.