Abstract
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).
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Data availability
Data are available from the corresponding author upon reasonable request.
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Acknowledgements
The authors gratefully acknowledge the patients who participated in the trial and the team members for their contributions to the trial.
Funding
This study was supported by the [National Natural Science Foundation of China] under Grant [81900524]; the [Natural Science Foundation of Shandong Province] under Grant [ZR2020MH252; ZR2020MH205; ZR2022MH085]; the China Postdoctoral Science Foundation under Grant [2020M672102]; the [Science and Technology Development Program of Jinan] under Grant [202134027].
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All authors contributed to the study conception and design. Financial and administrative support were performed by CJ and FT. Provision of study materials or patients were performed by GL, YC, LP and LL. Date collection and follow-up of the patients were performed by RF and JW. Data analysis and interpretation were performed by SS and WQ. The first draft of the manuscript was written by SS and all authors commented on previous versions of the manuscript.
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This study was performed in line with the principles of the Declaration of Helsinki. Study protocol was approved by the Ethics Committee of Shandong Provincial Hospital (SWYX: NO.2021–1013), and registered in the Chinese Clinical Trial Register (http://www.chictr.org.cn, ChiCTR2200056201).
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Sha, S., Qiao, W., Feng, R. et al. Somatostatin-analog effect on pancreatic fistula after radical gastrectomy: a pilot randomized controlled trial. J Cancer Res Clin Oncol 149, 6329–6339 (2023). https://doi.org/10.1007/s00432-023-04584-7
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DOI: https://doi.org/10.1007/s00432-023-04584-7