Somatostatin-analog effect on pancreatic fistula after radical gastrectomy: a pilot randomized controlled trial.

PURPOSE

Radical gastrectomy with D2 lymphadenectomy can trigger a high incidence of postoperative pancreatic fistula (POPF), which produces a poor clinical prognosis. We sought to evaluate the effect of somatostatin analogs (SSA) on POPF and clinical prognosis after radical gastrectomy.

METHODS

A total of 123 patients with a high risk of POPF after radical gastrectomy (drainage fluid amylase concentration on a postoperative day [POD] 1 > 3 times the upper limit of normal serum amylase value) were randomly divided into the SSA group (n = 61) and the control group (n = 62). The former received continuous intravenous SSA (0.3 mg/8 h) for 3 days from POD1, and the latter normal saline. The primary outcome was the incidence of POPF.

RESULTS

The incidence of POPFs in the SSA group was significantly lower than that in the control group (3.3% vs. 14.5%, P = 0.029). The incidence of short-term postoperative complications was significantly lower in the SSA group than in the control group (9.8% vs. 24.2%, P = 0.034). The median white blood cell counts, neutrophil counts, and the percentage of neutrophils on POD4 were significantly lower in the SSA group than in the control group (all P < 0.05). The SSA group had a shorter mean time to the first liquid diet (87.33 ± 17.92 h vs. 93.97 ± 17.29 h, P = 0.039). And the SSA group had less median daily drainage volume (96.33 mL vs. 119.67 mL, P = 0.025) and shorter drainage duration (7.0 days vs. 10.0 days, P = 0.013).

CONCLUSION

Postoperative treatment with a somatostatin analog reduced the incidence of POPF and short-term complications after radical gastrectomy. (TRN: ChiCTR2200056201, Reg. Date: 2022/2/1).