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 randomised 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.


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 x 3 days of therapy, during which, serum levels of somatostatin were measured daily. Pre- and posttreatment 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 pretreatment level was 17.1 pg/ml (SD: 7.5; range: 8-33), and posttreatment 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.
Roeyen
G
G
Department of Hepatobiliary, Endocrine and Transplantation Surgery, University Hospital of Antwerp, Wilrijkstraat 10, 2650 Edegem (Antwerpen), Belgium. geert.roeyen@uza.be
Chapelle
T
T
De Bosscher
H
H
Mattheeussen
E
E
Wouters
C
C
Ruppert
M
M
Ysebaert
D
D
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D006728:Hormones / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D007412:Intestinal Fistula / Q000097:blood / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010185:Pancreatic Fistula / Q000097:blood / Q000628:therapy*; D010289:Parenteral Nutrition, Total / Q000379:methods*; D013004:Somatostatin / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome
D006728:Hormones; D013004:Somatostatin