Botulinum toxin into the sphincter of Oddi did not reduce pancreatic fistula after distal pancreatectomy

Design

Monocentre, open-label, randomised phase 2 trial, stopped early for futility

Population

50 patients scheduled for elective primary distal pancreatectomy

Primary outcome

Grade B/C postoperative pancreatic fistula or death within 30 days

Effect

Fistula 28.6% vs 15% (P = 0.294)

Pancreatic fistula after distal pancreatectomy affects up to about 30% of patients. This single-centre, open-label, phase 2 randomised trial tested whether an endoscopic injection of 100 units of botulinum toxin into the sphincter of Oddi, 3 to 10 days before surgery, would improve drainage and prevent clinically relevant fistula.

Fifty patients were randomised, and the trial was stopped early for futility. The injection was technically successful in all 26 treated patients and no post-injection pancreatitis occurred. Clinically relevant fistula (grade B or C) occurred in 6 intervention patients and 3 controls (28.6% vs 15%, P = 0.294). One treated patient died from fistula-related haemorrhage.

The trial was small, so it cannot rule out a modest effect either way, but there was no sign of benefit even when the authors considered the most favourable outcome for the remaining planned patients. The authors conclude the findings do not support the approach.

• Preoperative sphincter of Oddi botulinum toxin did not reduce grade B/C fistula in this trial.
• The procedure was feasible and no post-injection pancreatitis was seen.
• Numbers were small; fistula was numerically higher in the treated group.
• Standard fistula-reduction measures remain the focus until better evidence appears.
• Use only within a trial if your unit is exploring it.

Why it matters

It closes a promising idea early and spares patients an extra endoscopic procedure.

Don't overread it

A phase 2, open-label, single-centre pilot cannot show harm either; it only fails to show benefit.

The statistics, in plain English

P = 0.294 with 6 versus 3 events means the difference could easily be chance, and with so few events a real effect in either direction cannot be excluded. The early stop for futility means the interim data showed no trend towards benefit.

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