Design: Single-centre, open-label, randomised phase 2 trial, stopped for futility
Population: 50 adults scheduled for elective distal pancreatectomy
Primary outcome: Clinically relevant pancreatic fistula (grade B/C) or death within 30 days
Effect: Fistula 28.6% with botulinum toxin vs 15% control (P = 0.29)

A single-centre, open-label phase 2 trial randomised 50 patients scheduled for distal pancreatectomy to endoscopic injection of 100 units of botulinum toxin into the sphincter of Oddi 3 to 10 days before surgery, or no intervention. The idea is that relaxing the sphincter lets pancreatic juice drain to the duodenum rather than through the stump.

All injections succeeded and none caused pancreatitis. But clinically relevant pancreatic fistula occurred in 28.6% of the injection group and 15% of controls, and one patient in the injection group died after fistula-related haemorrhage. The trial was stopped early for futility.

The trial was small and the difference was not statistically significant, so it does not show harm. It does show no sign of benefit, and an extra endoscopy before surgery is not free.

Fistula after distal pancreatectomy remains common, and there is still no reliable preventive manoeuvre beyond careful stump closure and drain management.

Do not offer preoperative sphincter of Oddi botulinum toxin to prevent fistula outside a trial.
Expect clinically relevant fistula in up to about one in four or five distal pancreatectomies.
Monitor drain amylase and watch for haemorrhage in patients with fistula.
Counsel patients that fistula prevention remains an unsolved problem.

Why it matters

It closes off a promising-sounding route to preventing the commonest complication of distal pancreatectomy.

The statistics, in plain English

28.6% against 15% looks worse with toxin, but with 50 patients the P value of 0.29 means chance easily explains it. A futility stop means the trial could not plausibly have shown benefit even if completed.