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A new "sandwich" method of combined endoscopic variceal ligation and sclerotherapy versus ligation alone in the treatment of esophageal variceal bleeding: a randomized trial.

BACKGROUND
Variceal ligation is the optimum endoscopic method for treating esophageal variceal bleeding. However, both early and multiple recurrences of esophageal varices frequently follow ligation. The aim of this randomized study was to determine whether a new, combined endoscopic "sandwich" method (i.e., ligation-sclerotherapy-ligation) could achieve better results than ligation alone.


METHODS
Ninety-four patients with cirrhosis and acute or recent esophageal variceal bleeding were randomized to undergo either the "sandwich" method or ligation alone (47 patients in each group).


RESULTS
The sclerosant was retained in the varices for more than 30 minutes in 7 of 8 patients undergoing the "sandwich" method plus radiographic contrast medium. Active bleeding was controlled with this new method (9/9) as efficiently as ligation (12/12). The rate of recurrent bleeding was similar for both methods. Multivariate analysis showed the necessity for the use of antibiotics (odds ratio 3.95: 95% CI [1.60, 9.76]) to be an independent factor for recurrent bleeding. Two patients in the "sandwich" group developed strictures, but the frequency of other complications did not differ between the 2 groups. Kaplan-Meier analysis showed the cumulative probability of variceal recurrence was lower with the "sandwich" method (p = 0.0391). The survival rate and causes of death were similar in both groups.


CONCLUSIONS
The "sandwich" method leads to longer retention of sclerosant in varices. This method is superior to ligation alone in terms of lower variceal recurrence rate and comparable to ligation with respect to hemostasis. However, it is unknown whether the lower recurrence rate of varices will persist long-term.