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A randomised, multicentre trial of somatostatin to prevent clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy

Abstract

Background

Prophylactic somatostatin to reduce the incidence of clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy remains controversial. We assessed the preventive efficacy of somatostatin on clinically relevant postoperative pancreatic fistula in intermediate-risk patients who underwent pancreaticoduodenectomy at pancreatic centres in China.

Methods

In this multicentre, prospective, randomised controlled trial, we used the updated postoperative pancreatic fistula classification criteria and cases were confirmed by an independent data monitoring committee to improve comparability between centres. The primary endpoint was the rate of clinically relevant postoperative pancreatic fistula within 30 days after pancreaticoduodenectomy.

Results

Eligible patients (randomised, n = 205; final analysis, n = 199) were randomised to receive postoperative intravenous somatostatin (250 μg/h over 120 h; n = 99) or conventional therapy (n = 100). The primary endpoint was significantly lower in the somatostatin vs control group (n = 13 vs n = 25; 13% vs 25%, P = 0.032). There were no significant differences for biochemical leak (P = 0.289), biliary fistula (P = 0.986), abdominal infection (P = 0.829), chylous fistula (P = 0.748), late postoperative haemorrhage (P = 0.237), mean length of hospital stay (P = 0.512), medical costs (P = 0.917), reoperation rate (P > 0.99), or 30 days’ readmission rate (P = 0.361). The somatostatin group had a higher rate of delayed gastric emptying vs control (n = 33 vs n = 21; 33% vs 21%, P = 0.050).

Conclusions

Prophylactic somatostatin treatment reduced clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy.

Trial registration

NCT03349424.

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Acknowledgements

Writing support was provided by Sarah Bubeck, PhD, of Edanz Pharma. This study was funded by Merck Serono Ltd., Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany.

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Authors

Contributions

Conception and design: TZ, BS, RQ, RC, YM, WL, YZ; Administrative support: JG, TZ, BS, RQ, RC, YM, WL, YZ; Provision of study materials or patients: JG, TZ, BS, RQ, RC, YM, WL, YZ; Collection and assembly of data: ZC, JQ, JG, GX, KJ, SZ, TK, YW; Data analysis and interpretation: ZC, JQ, JG, GX, KJ, SZ, TK, YW; Manuscript writing: all authors; Final approval of manuscript: all authors.

Corresponding authors

Correspondence to Taiping Zhang or Yupei Zhao.

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The authors declare that they have no competing interest.

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Cite this article

Cao, Z., Qiu, J., Guo, J. et al. A randomised, multicentre trial of somatostatin to prevent clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy. J Gastroenterol 56, 938–948 (2021). https://doi.org/10.1007/s00535-021-01818-8

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Keywords

  • Clinically relevant postoperative pancreatic fistula
  • Intermediate-risk
  • Pancreaticoduodenectomy
  • Somatostatin