Clinical and economic study of the use of somatostatin 14 AA (amino-acids) in the treatment of enterocutaneous and pancreatic fistulas

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Purposes of the study

To describe the use of somatostatin 14 AA (amino-acids) by patients with post-surgical enterocutaneous and/or pancreatic fistulas, its clinical results, and the analysis of the economic benefits resulting from such treatment.

Material and methods

Nature of the study: open medico-economic observational study. Follow-up period of the patients: from somatostatin 14 AA treatment initiation to the closure of the fistula (fistula output ≤ 10 ml/24 h) or to a maximum of 28 days. Criteria of selection: presence of one or more entero-cutaneous and/or pancreatic post-surgical fistulas. Evaluation criteria: 1) closure rate and time to closure of the fistulas; 2) hospital expenses.

Results

Eighty patients were included in the study. The average age of the patients was 58.4 ± 16.6 years (mean ± SD). 87.7% (n=64) of the patients had single fistula and 12.3% (n=9) had multiple fistulas. 37.0% (n=27) were ileal, 17.8% (n=13) jejunal and 45.2% (n=33) pancreatic. 60.8% fistulas were closed after 15.2 ± 7.6 days and 11.5 ± 5.1 days of treatment. The percentage of closure is comparable whatever the clinical characteristics (age, sex, associated pathology) of the patients, the conditions of the surgical operation (first intervention or re-intervention, regular or emergency surgery) and the type of fistula (ASA classification, morphology, topography). The percentage of closure varies significantly according to the response at 48 h. Respectively, among the patients who have a decrease of 50% and 70% of their fistula output at 48 h, 80% (n=32) and 91.7% (n=22) have an output less than 10 ml/24 h at the end of the study. The rate of closure of the fistula does not differ from those described in the literature for treatments without somatostatin 14 AA but the time of closure is halved from 31 days to 15.2 days. At comparable therapeutic success rate, the use of somatostatin 14 AA provides greater comfort for the patient and an important decrease in costs (30%) arising from the reduction in the duration of the hospital stay.

Conclusion

The use of somatostatin 14 AA shortens the time of closure of the enterocutaneous and pancreatic fistulas and allows an important reduction of the hospital costs. The evaluation of the therapeutic response 48 h after the beginning of the treatment is a fundamental criterion for optimising the use of this drug.