The potent somatostatin analogue vapreotide does not decrease pancreas-specific complications after elective pancreatectomy: a prospective, multicenter, double-blinded, randomized, placebo-controlled trial

J Am Coll Surg. 2003 Apr;196(4):556-64; discussion 564-5; author reply 565. doi: 10.1016/S1072-7515(03)00104-2.

Abstract

Background: Pancreatectomy can be complicated by pancreatic anastomotic leakage, causing major morbidity.

Study design: Our aim was to determine if vapreotide, a potent long-acting somatostatin analogue, would decrease pancreas-related complications. This prospective, multicenter, randomized, double-blind, placebo-controlled trial involved 275 patients without preexisting chronic pancreatitis undergoing elective proximal, central, or distal pancreatectomy. Complications were defined by objective criteria before beginning the study.

Results: One hundred thirty-five patients received vapreotide; 140 patients received placebo. There were no statistically significant differences between vapreotide- and placebo-treated patients in either pancreas-related complications (30.4% versus 26.4%, respectively) or in other complications not directly related to the pancreas (40% versus 42%, respectively).

Conclusions: The potent somatostatin analogue vapreotide does not appear to decrease postoperative complications after major pancreatectomy in patients without chronic pancreatitis.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Double-Blind Method
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Pancreatectomy*
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control*
  • Prospective Studies
  • Risk Factors
  • Somatostatin / analogs & derivatives*
  • Somatostatin / therapeutic use*

Substances

  • vapreotide
  • Somatostatin