Somatostatin and octreotide both enhance closure of gastrointestinal fistulas. The present trial was undertaken to test whether early combined treatment with parenteral nutrition and octreotide 100 micrograms every 8 h by subcutaneous injection had a beneficial effect compared with parenteral nutrition plus placebo. Thirty-one patients with post-operative gastrointestinal or pancreatic fistula were randomly assigned to receive parenteral nutrition plus octreotide (14 patients) or placebo (17) within 8 days of fistula onset. The percentage reduction in output and rate of spontaneous closure within 20 days were analysed. Mean(s.d.) reduction in output was similar after octreotide and placebo at 24 h (66(43) versus 68(47) per cent, P = 0.9), 48 h (60(46) versus 57(43) per cent, P = 0.8) and 72 h (62(50) versus 66(49) per cent, P = 0.9) after starting the combined treatment. Closure within 20 days was observed in eight of 14 fistulas in patients given octreotide and in six of 17 in those receiving placebo (P = 0.4). Administration of octreotide, within 8 days of fistula onset, associated with parenteral nutrition does not significantly increase the spontaneous fistula closure rate compared with parenteral nutrition plus placebo.
Twenty-seven patients with postoperative enterocutaneous fistulas were treated with parenteral nutrition and SMS 201-995 (100 micrograms/8 hours, subcutaneously), a long half-life somatostatin analogue. At the time SMS 201-995 was started, 11 patients had low output fistulas (less than 1000 ml/48 hours), 11 patients had high output fistulas (above 1000 ml/48 hours), and 5 patients had fistulas sitting in large abdominal wall defects. Within 24 hours of treatment, a mean reduction of 55% of the fistula output was observed. Fistula site or output before treatment had no influence on the magnitude of output reduction. Spontaneous closure was achieved in 77% of the patients after a mean of 5.8 +/- 2.7 days of treatment with this drug. Two patients died (7.4%). Pain at the injection site was referred by 15% of the patients but no other side effects were observed. Glucose intolerance was not observed. SMS 201-995 has been shown to be very useful in the conservative treatment of enterocutaneous fistulas because of its ability to rapidly reduce fistula output and accelerate spontaneous closure.
Pharmacological treatment of patients with enterocutaneous fistulas aims at reducing output, increasing the chance of spontaneous closure and reducing the time of fistula closure. Our initial experience with octreotide suggests that this drug effectively reduces output of established enterocutaneous fistulas when compared with a placebo in patients on parenteral nutrition. Output reduction was independent of the basal output. Likewise, this somatostatin analogue was shown to accelerate fistula closure in a series of 27 patients treated with the drug after having received parenteral nutrition for a mean of 25 days. When compared with a historical series, the rate of spontaneous fistula closure was not modified by octreotide.
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