Addition of somatostatin-14 to a standard Total Parenteral Nutrition-mixture in the treatment of fistulae : a clinical, double-blind, randomised, cross-over study

Background / study aims : Somatostatin and total parenteral nutrition (TPN) are routinely used in the treatment of pancreatic and enterocutaneous fistulae. The objective of this clinical ran- domised cross-over study was to investigate the serum levels of somatostatin infused alongside TPN by a separate intravenous line, and when it had been added to the TPN mixture. Patients / methods : The subjects were recruited by the treating physicians and the nutrition nurses. From the patients who started the study, no one dropped out. Ten patients were treated with a standard TPN mixture and somatostatin 6 mg/day. Patients were randomised to two possible regimens : 'somatostatin plus TPN - somatostatin separately - somatostatin plus TPN' or 'somatostatin separately - somatostatin plus TPN - somatostatin separately'. Each regimen consisted of 3 ?? 3 days of therapy, during which, serum levels of somatostatin were measured daily. Pre- and post- treatment samples were also analysed. Results : When somatostatin was infused separately, the mean serum level was 884.8 pg/ml (SD : 557.3 ; range : 54-1900). When added to TPN, the mean serum level was 807.5 pg/ml (SD: 505.8 ; range 162-2279) (p value of difference = 0,473). The mean pre- treatment level was 17.1 pg/ml (SD : 7.5 ; range : 8-33), and post- treatment was 32.8 pg/ml (SD : 26.5 ; range : 16-97). Conclusions : These results demonstrate that serum levels of somatostatin are similar in both treatment regimens and therefore may be added to a TPN mixture. Sponsorship : This study was performed with an unconditional Educational Grant from UCB-Belgium. The authors did not have any conflict of interest in UCB-Belgium. (Acta gastroenterol. belg., 2008, 71, 246-249).