Trial of sclerosing agents in patients with oesophageal varices.
Forty-five cirrhotic patients with oesophageal varices underwent endoscopic injection sclerotherapy in a prospective randomized trial carried out to compare two sclerosing agents (5 per cent ethanolamine oleate and 2 per cent sodium tetradecyl sulphate (STD] with respect to safety, efficacy and complications. Twenty-three patients were allocated to the ethanolamine group and twenty-two to the STD group. The rate of control of acute bleeding was 100 per cent (6/6) in the ethanolamine group and 75 per cent (3/4) in the STD group. There was a significantly lower rate of postinjection bleeding after the over-tube was removed at the initial session of sclerotherapy when ethanolamine was injected 0/23 versus 7/22, 32 per cent; P less than 0.01) and at the second session there was a significantly (P less than 0.01) higher rate of jet-like bleeding from injection sites in the STD group (6/21, 29 per cent) than in the ethanolamine group (0/22). The disappearance rate of red colour signs 1 week after the initial session of sclerotherapy in the ethanolamine group was 100 per cent and 62 per cent in the STD group. Early oesophageal ulcers developed less frequently in the ethanolamine group (0 and 9 per cent) than in the STD group (24 per cent and 43 per cent both after the initial (P less than 0.05) and the second session of sclerotherapy (P less than 0.01]. Early bleeding from an oesophageal ulcer occurred only in the STD group (5/21, 24 per cent) before the third session of sclerotherapy (P less than 0.05). The rate of early mortality did not differ between the two groups. We conclude that ethanolamine seems to be safer and more efficacious than STD for sclerosing oesophageal varices.
D002986:Clinical Trials as Topic; D004724:Endoscopy; D004932:Esophageal and Gastric Varices / Q000628:therapy*; D004983:Ethanolamines / Q000009:adverse effects; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009829:Oleic Acids / Q000627:therapeutic use; D011446:Prospective Studies; D011897:Random Allocation; D012597:Sclerosing Solutions / Q000009:adverse effects / Q000627:therapeutic use*; D012981:Sodium Tetradecyl Sulfate / Q000009:adverse effects / Q000627:therapeutic use
D004983:Ethanolamines; D009829:Oleic Acids; D012597:Sclerosing Solutions; D012981:Sodium Tetradecyl Sulfate; C033343:ethanolamine oleate