PREBOTPilot Trial: Botulinum Toxin Injection Into the Sphincter of Oddi Fails to Prevent Pancreatic Fistula After Distal Pancreatectomy

Highlight

  • Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi (SO) was safe and feasible in patients undergoing distal pancreatectomy (DP).
  • BTX injection did not reduce the rate of clinically relevant postoperative pancreatic fistula (POPF) grades B/C or 30-day mortality compared to control.
  • The PREBOTPilot randomized controlled trial was prematurely terminated due to futility after interim analysis.
  • Findings do not support routine use of SO BTX injection for POPF prevention following DP.

Study Background

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