A prospective randomized controlled trial of sclerotherapy vs ligation in the prophylactic treatment of high-risk esophageal varices

Background: Endoscopic ligation (EVL) and endoscopic sclerotherapy (EIS) are both effective in the treatment of bleeding esophageal varices, but the efficacy of the two techniques in the prophylaxis of first variceal bleeding has not been investigated. The aim of this study was to investigate the frequency of first variceal bleeding, the recurrence of varices, and survival after treatment with the two techniques, as compared to a nontreated control group. Methods: A total of 157 patients with liver cirrhosis and advanced esophageal varices with no previous history of upper gastrointestinal bleeding were randomly assigned to either an EIS group (n= 55), an EVL group (n= 52), or a nontreated control group (n= 50). After the eradication of esophageal varices in the EIS and in EVL groups and in all control patients, the endoscopic examination was performed at 3-month intervals. Results: There were no significant differences between EIS and EVL in the eradication rate of esophageal varices (85% in the EIS group versus 81% in the EVL group). The mean number of sessions required to obtain eradication was lower in the EVL group than in the EIS group (4.8 ± 1.8 versus 6.2 ± 2.0; p= 0.0003), but the recurrence of esophageal varices was higher in the EVL group (31% versus 11%; p= 0.01). Total mortality was significantly lower in the EIS patients than in the controls (20% versus 38%; p= 0.04). It was also lower, but not significantly, in the EVL patients than in the controls (23% versus 38%; p= 0.10). A significant decrease in variceal bleeding was observed both in sclerotherapy cases (20%) and controls (54%; p= 0.0005) and in ligation cases and controls (29%; p= 0.01). No significant difference in bleeding episodes was observed between the sclerotherapy and ligation cases (p= 0.29). No serious complications were observed either in the EIS or EVL groups. Conclusions: EIS and EVL are similarly effective in the prevention of first variceal bleeding. The choice between EIS and EVL depends on the skill of the endoscopic unit. For highly experienced surgeons facing no complications, sclerotherapy seems to be preferable; for all others, it is technically easier to perform ligation. Received: 29 June 1998/Accepted: 18 September 1998