rate could be lowered [5] and survival prolonged. 9,10 Studies Patients who have bled from varices remain at risk with rubber band ligation have shown that in addition to for rebleeding. There is interest in methods that would being safer than sclerotherapy, 11-14 ligation can further lower enable rapid eradication of varices. The present trial the rebleeding rate 12,13 and further improve survival. 11 Howwas designed to study whether combining ligation with ever, the problem of rebleeding has not been eliminated. Besclerotherapy will allow quicker eradication of varices cause most episodes of rebleeding occur early, methods that than either modality alone. Patients with bleeding eradicate varices more rapidly by reducing the ''period at esophageal varices were randomized into ligation or risk'' might further improve outcome.
combination therapy groups. Patients in the ligation
In our first multicenter trial, an average of five sessions group were treated with endoscopic rubber band ligawere required to eradicate varices with sclerotherapy, tion alone. In combination group patients, each variceal whereas four sessions were required with ligation. 11 To furcolumn was ligated distally and 1 mL of ethanolamine ther optimize efficiency, we asked whether a lower dose of was injected proximal to each ligated site. Subsequent sclerotherapy in conjunction with ligation would eradicate treatment sessions were at 7-to 14-day intervals until esophageal varices more quickly than either modality alone, varices were eradicated. The clinical and endoscopic while maintaining the lower complication rate associated characteristics of 25 patients in the ligation group were with ligation. In an initial single-arm study, we ligated each similar to those of 22 patients in the combination group.
variceal column distally and injected 1 mL of sclerosing solu-Follow-up was up to 30 months. Active bleeding was contion proximal to each ligated site. With this approach, varices trolled in 100% of patients in the ligation group and 75%
were eradicated with an average of approximately three sesof those in combination group (P ร
NS). It took 3.3 { .4
sions. 15 The aim of the present prospective randomized trial (range, 1-7) sessions to eradicate varices with ligation was to determine whether combination therapy would eradiand 4.1 { .6 (1-7) with combination therapy (P ร
NS).
cate varices more quickly than ligation alone. Survival (four deaths in ligation group, 8 in combination group), rebleeding rate (25% vs. 36%), and varix recur-PATIENTS AND METHODS rence (16% vs. 23%) also were similar. There were more complications with combination therapy, including Patient Selection and Randomization deep ulcers (65% vs. 20%; P รต .05); dysphagia (30% vs. 0%;