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

  • Original Article—Liver, Pancreas, and Biliary Tract
  • Published:
Journal of Gastroenterology Aims and scope Submit manuscript

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.

Author information

Author notes

  1. Shangyou Zheng & Rufu Chen

    Present address: Department of General Surgery, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangdong, China

  2. Zhe Cao and Jiangdong Qiu should be considered joint first authors.

Authors and Affiliations

  1. Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

    Zhe Cao, Jiangdong Qiu, Junchao Guo, Taiping Zhang & Yupei Zhao

  2. Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei, China

    Guangbing Xiong & Renyi Qin

  3. Department of General Surgery, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China

    Kuirong Jiang & Yi Miao

  4. Department of Hepato-Pancreato-Biliary Surgery, Sun Yat-Sen Memorial Hospital, Guangdong, China

    Shangyou Zheng & Rufu Chen

  5. Department of Pancreatic Surgery, Zhong Shan Hospital, Fudan University, Shanghai, China

    Tiantao Kuang & Wenhui Lou

  6. Department of Pancreatic and Biliary Surgery, Key Laboratory of Hepatosplenic Surgery, Ministry of Education, The First Affiliated Hospital of Harbin Medical University, Heilongjiang, China

    Yongwei Wang & Bei Sun

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  1. Zhe Cao
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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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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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  • DOI: https://doi.org/10.1007/s00535-021-01818-8

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