Human thrombin plus 5 per cent ethanolamine oleate injected to sclerose oesophageal varices: A prospective randomized trial

Fifty cirrhotic Japanese patients with oesophageal varices underwent sclerotherapy in a prospective randomized trial carried out to examine the effects of human thrombin given concomitantly with the sclerosant 5 percent ethanolamine oleate. The two groups (25 patients each) were comparable with regard to size of the oesophageal varices, and the aetiology and severity of the liver disease. Twenty‐five patients, 13 and 12 in the thrombin + and ‐ groups, respectively, had at least one episode of variceal bleeding. The remaining 25 were given prophylactic injections. There was a significantly lower rate of occurrence of bleeding from injection sites when the injection needle was removed at the initial session of sclerotherapy in the thrombin + group, where human thrombin was injected (0·2‐0·3 ml, 100–150 units per injection) just before removal of the injection needle. Endoscopy at 1 week after the initial session showed a significantly (P < 0·05) higher rate of disappearance of red colour signs on varices in the thrombin + group (96 per cent) than in the thrombin ‐ group (72 per cent). Fibrin degradation product E‐fraction (FDP‐E) values increased 1 h, 1 day and 6 days after the initial session of sclerotherapy in the two groups. The rate of increase in FDP‐E values 1 h after sclerotherapy was significantly larger (P < 0·001) in the thrombin + than in the thrombin ‐ group. There was no clinical sign of disseminated intravascular coagulation. Administration of human thrombin plus a sclerosant seems to be useful and efficacious, especially for patients with huge oesophageal varices.