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A randomised, multicentre trial of somatostatin to prevent clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy.
- Source :
-
Journal of gastroenterology [J Gastroenterol] 2021 Oct; Vol. 56 (10), pp. 938-948. Date of Electronic Publication: 2021 Aug 28. - Publication Year :
- 2021
-
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.<br />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.<br />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).<br />Conclusions: Prophylactic somatostatin treatment reduced clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy.<br />Trial Registration: NCT03349424.<br /> (© 2021. Japanese Society of Gastroenterology.)
- Subjects :
- Aged
China epidemiology
Female
Hormones administration & dosage
Hormones pharmacology
Hormones therapeutic use
Humans
Male
Middle Aged
Pancreas drug effects
Pancreas physiopathology
Pancreas surgery
Pancreatic Fistula drug therapy
Pancreaticoduodenectomy methods
Postoperative Complications drug therapy
Postoperative Complications prevention & control
Prospective Studies
Somatostatin administration & dosage
Somatostatin therapeutic use
Pancreatic Fistula prevention & control
Pancreaticoduodenectomy adverse effects
Somatostatin pharmacology
Subjects
Details
- Language :
- English
- ISSN :
- 1435-5922
- Volume :
- 56
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Journal of gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 34453212
- Full Text :
- https://doi.org/10.1007/s00535-021-01818-8