Long-term follow up of a randomized, controlled trial on prophylactic sclerotherapy of small oesophageal varices in liver cirrhosis

Abstract

Background: In order to evaluate the prophylactic impact of sclerotherapy of small varices in patients with cirrhosis and no endoscopic signs suggesting risk of haemorrhage, a randomized clinical trial was performed.

Methods: Seventy-one hospitalized patients met the inclusion criteria of diagnosis of cirrhosis with no previous bleeding and small varices. Due to exclusion criteria of: gastroduodenal ulcers (n = 5), diverticulosis (n = 1), hepatic insufficiency (n = 10), hepatocellular carcinoma (n = 4), death before randomization (n = 6), age over 70 (n = 1) and denial of consent to participate in the study (n = 1), 43 patients could be randomized, 21 for sclerotherapy and 22 for the control group. Two patients (one in each group) were lost to follow up, and another patient, although not lost, refused sclerotherapy after randomization. Ethanolamine oleate was used as the sclerosing agent. All patients were followed up for a mean time of 60 months, initially every 2 months for the first 2 years and clinical and endoscopic controls were performed each 6-12 months thereafter.

Results and conclusions: During the first 2 years clinical assessment showed that there were five bleedings in the sclerotherapy group and none in the control group, but mortality was similar in both groups. Long-term follow up continued to show a higher prevalence of bleeding in the sclerotherapy group but that mortality was not different from the control group.