BACKGROUND: Experimental and clinical studies on the effect of octreotide in the treatment of patients with acute pancreatitis have presented controversial results. Since January 1992, we have been conducting a prospective randomized study on the clinical effect of octreotide in severe acute pancreatitis, at three hospitals in Israel. STUDY DESIGN: The entering criteria included three or more of the Ranson's prognostic signs and computed tomographic findings of severe pancreatitis. Patients were randomly assigned to conservative treatment either with or without octreotide (0.1 mg injected subcutaneously three times a day). The end points of the study included: complication rate (adult respiratory distress syndrome [ARDS], sepsis, renal failure, pseudocyst, fistula, and abscess), length of hospital stay, and mortality. RESULTS:During the first two years (from January 1992 to December 1993), 51 patients entered the study. After evaluation, 13 patients were excluded due to failure to meet the entering criteria, incomplete data, or incorrect diagnosis. Of the remaining 38 patients, 19 were assigned to octreotide (treatment group) and 19 to conservative treatment alone (control group). The two groups were matched with regard to age, sex, etiology, and severity of disease. The complication rate was lower in the treatment group compared with the control group with regard to sepsis (26 compared with 74 percent, p = 0.004) and ARDS (37 compared with 63 percent, p = 0.1). The hospital stay was shorter in the treatment group compared with the control group (17.9 compared with 34.1 days, p = 0.02). Death occurred in two patients in the treatment group and six patients in the control group. CONCLUSIONS: Although some of the parameters did not reach statistical significance, these preliminary results suggest that octreotide may have a beneficial effect in the treatment of patients with severe acute pancreatitis. This study is scheduled to continue for two more years.
RCT Entities:
BACKGROUND: Experimental and clinical studies on the effect of octreotide in the treatment of patients with acute pancreatitis have presented controversial results. Since January 1992, we have been conducting a prospective randomized study on the clinical effect of octreotide in severe acute pancreatitis, at three hospitals in Israel. STUDY DESIGN: The entering criteria included three or more of the Ranson's prognostic signs and computed tomographic findings of severe pancreatitis. Patients were randomly assigned to conservative treatment either with or without octreotide (0.1 mg injected subcutaneously three times a day). The end points of the study included: complication rate (adult respiratory distress syndrome [ARDS], sepsis, renal failure, pseudocyst, fistula, and abscess), length of hospital stay, and mortality. RESULTS: During the first two years (from January 1992 to December 1993), 51 patients entered the study. After evaluation, 13 patients were excluded due to failure to meet the entering criteria, incomplete data, or incorrect diagnosis. Of the remaining 38 patients, 19 were assigned to octreotide (treatment group) and 19 to conservative treatment alone (control group). The two groups were matched with regard to age, sex, etiology, and severity of disease. The complication rate was lower in the treatment group compared with the control group with regard to sepsis (26 compared with 74 percent, p = 0.004) and ARDS (37 compared with 63 percent, p = 0.1). The hospital stay was shorter in the treatment group compared with the control group (17.9 compared with 34.1 days, p = 0.02). Death occurred in two patients in the treatment group and six patients in the control group. CONCLUSIONS: Although some of the parameters did not reach statistical significance, these preliminary results suggest that octreotide may have a beneficial effect in the treatment of patients with severe acute pancreatitis. This study is scheduled to continue for two more years.