Studies on the effects of somatostatin-14 and octreotide on fistula closure rates and times
| Time to closure (days) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Patient population | Evidence level1 | Dose of S/O | Treatment | n | Closure (%) | Mortality (%) | TPN/PN (+placebo) | TPN/PN prior to S/O+TPN/PN | S/O+TPN/PN | Significant effect on closure time? |
| EC, enterocutaneous; ext, external; HO, high output; LO, low output; NA, not applicable; ND, no data; O, octreotide; oesoph, oesophageal; panc, pancreatic; Pl, placebo; PO, postoperative; PN, parenteral nutrition; S, somatostatin-14. | |||||||||||
| 1Evidence level7 Ia, meta-analysis of randomised controlled trials (RCTs); Ib, RCT; IIa, non-randomised controlled study; IIb, quasi-experimental study; III, non-experimental descriptive studies; IV, expert committee reports; opinions or clinical experience of respected authorities. 2On day 14. 3Within 20 days. 4Patients received octreotide for two days, TPN for two days, and then octreotide until closure or operation, or TPN for two days, octreotide for two days, and then octreotide until closure or operation. 5After continuous octreotide. 6Historical controls. 7The total time to closure in the somatostatin-14 group (18.2 (6.3 days)) was significantly less than that in the TPN group (27.4 (8.7 days)) (p<0.01). 819 fistulae in 18 patients. 9Conservative treatment not mentioned. 10Only 10 days of octreotide. 116/8 received TPN, 2/8 received a fat free polymeric enteral diet. | |||||||||||
| Torres et al 199223 | All PO: 7 panc, 5 duodenum, 7 jejunum, | Ib | 250 μg/h | TPN | 20 | 81 | 0 | 20.4 (3.0) | p<0.05 | ||
| 18 ileum, 3 ileocolic | S+TPN | 20 | 85 | 0 | 2–3 | 13.9 (1.8) | |||||
| Isenmann et al 199437 | All PO, ext: 20 panc, 21 small intestine, 4 | Ib | 250 μg/h, up to 500 | TPN | 20 | 192 | ND | 19 | p=0.013 | ||
| biliary tract | μg/h | S+TPN | 25 | 782 | ND | 7 | 12.5 | ||||
| Sancho et al 199524 | All PO, ext: 1 stomach, 5 panc, 11 | Ib | 100 μg tid | Pl+TPN | 17 | 353 | 12 | 12 (7) | NS | ||
| duodenum, 5 jejunum, 9 ileum | O+TPN | 14 | 573 | 14 | 0 | 7 (3) | |||||
| Nubiola-Calonge et al 198727 | All PO: 2 duodenal, 9 jejunal, 3 ileal | Ib | 75–100 μg tid | (Pl,O,O)4+PN | 6 | 78 | ND | NA | ≥7 | 4.5 (2–10)5 | NA |
| (O,Pl,O)4+PN | 8 | ||||||||||
| Hernández-Aranda et al 199638 | All PO, ext. Mainly small intestine, HO | Ib | 100 μg tid | TPN | 45 | 56 | 31 | 27 (15) | p=0.002 | ||
| O+TPN | 40 | 65 | 25 | ND | 18 (11) | ||||||
| Pederzoli et al 198612 | All ext, panc, HO, PO | IIa | 250 μg/h for 3–4 days, | TPN | 18 | 94 | ND | 31.8 (21.1) | p=0.000028 | ||
| then 125 μg/h | S+TPN | 8 | 88 | ND | 6.6 (3.0) | ||||||
| Planas et al 199029 | All PO, EC (small intestine) | IIa | 3.5 μg/kg bolus, 3.5 | TPN | 46 | 30 | 28 | 29.7 (18.0) | p<0.05 | ||
| μg/kg/h | S+TPN | 15 | 53 | 13 | ND | 11.1 (1.6) | |||||
| Spiliotis et al 199039 | All PO, HO, ext: 16 gastroduodenal, 15 | IIa | 250 μg/h | TPN6 | 30 | 67 | 10 | 27.4 (8.7) | p<0.017 | ||
| small bowel, 6 choledochoduodenosto my, 11 panc | S+TPN | 18 | 78 | 6 | 15.3 (6–25) | 6.1 (3.1) | |||||
| Hild et al 198631 | All PO, ext: 9 gastric/duodenum, 8 jejunum, 4 ileal, 11 panc, 3 bile duct | IIb | 250 μg/h | S+PN | 35 | 80 | ND | NA | 18 | 11.3 | NA |
| Saari et al 198940 | All panc | IIb | 250 μg bolus, then 250 μg/h | S+TPN | 198 | 68 | ND | NA | 10 (0–40) | 7 (2–14) | NA |
| Ysebaert et al 199430 | All PO, ext: 6 panc, 5 duodenum, 3 jejunum, 9 ileum | IIb | 250 μg/h | S+TPN | 23 | 83 | ND | NA | ND | 11.0 (7.9) | NA |
| di Costanzo et al 198713 | All ext: 1 oesoph, 2 stomach, 9 duodenum, 3 biliary tract, 5 panc, 8 jejunum, 7 ileum, 2 colon | IIb | 250 μg/h | S+TPN | 37 | 82 | 13 | NA | 21.2 (3.8) (1–123) | 5.4 (0.7) (1–14) | NA |
| Nubiola et al 198934 | All PO, EC: 11 LO, 11 HO, 5 in large abdominal wall defects | IIb | 100 μg tid | O+PN | 27 | 78 | 7 | NA | 25 (2–98) | 5.8 (2.7) | NA |
| Barnes et al 199332 | All ext, panc: 8 HO, 4 LO | III | 50 μg bid up to 200 μg tid | O9 | 12 | 58 | ND | NA | 1 w–11 m | 3 d–7 m | NA |
| Lansden et al 198933 | All ext, panc: 3 LO, 2 HO | III | 50 μg bid up to 150 μg tid | O9 | 5 | 100 | ND | NA | 28–132 | 24 (7–44) | NA |
| Spiliotis et al 199441 | All PO, ext, panc | III | 100 μg tid | O10+TPN | 25 | 76 | ND | NA | ND | 14.1 (2.3 | NA |
| Segal et al 199342 | All HO, ext, panc | III | 100 μg tid | O (+TPN11) | 8 | 88 | 0 | NA | ND | 23 (5) (14–54) | NA |
| Tulassay et al 199335 | All HO, PO, ext, panc | III | 100 μg bid | O+PN | 16 | 88 | ND | NA | 17 (4–35) | 8 (3–15) | NA |