Fluorescence tracked with 38% less bile duct injury across 1.27 million cholecystectomies

Design

Retrospective cohort with inverse probability of treatment weighting

Population

1,266,024 adults undergoing laparoscopic cholecystectomy across multiple US hospitals, 2016–2024

Primary outcome

Common bile duct injury within 1 year

Effect

0.25% with fluorescence vs 0.40% without; relative risk 0.62 (95% CI 0.49–0.79)

Common bile duct injury is rare and catastrophic, which is exactly the combination that defeats randomised trials: the event rate is so low that a trial large enough to detect a difference has never been run. This cohort substitutes scale for randomisation — 1,266,024 laparoscopic cholecystectomies from 2016 to 2024, of which 164,695 used indocyanine green fluorescence cholangiography.

After inverse probability of treatment weighting, fluorescence was associated with common bile duct injury in 0.25% versus 0.40%, a relative risk of 0.62 (95% CI 0.49–0.79). Subsequent biliary intervention within a year fell from 5.39% to 4.49%, and conversion to open surgery from 0.84% to 0.40% — a halving. Non-biliary complications at 30 days were also lower, which is the result that should give a careful reader pause: fluorescence has no plausible mechanism for reducing wound infection or ileus, so its presence suggests residual confounding by the kind of surgeon and the kind of unit that adopts it.

Even granting that, the direction and size of the biliary findings are hard to dismiss, and the intervention is cheap, quick and carries essentially no risk. Uptake rose from 1.6% of cases in 2016 to 26% in 2024, so the comparison is increasingly between early and late adopters rather than between enthusiasts and refusers.

• Give the dye with enough lead time — biliary excretion needs time, and a dose at induction underperforms one given earlier
• Use it to confirm anatomy before division, not to explain an injury afterwards
• It supplements the critical view of safety; it does not replace it
• Most modern laparoscopic stacks already have the near-infrared mode — check before assuming capital spend is needed
• Indocyanine green is contraindicated in iodine allergy; ask before the scrub

Why it matters

For the one complication general surgeons most fear, this is the largest body of evidence that is ever likely to exist, because the trial cannot be run.

Don't overread it

This is an observational cohort. Fluorescence was associated with fewer injuries; it has not been shown to prevent them. The parallel reduction in non-biliary complications is a warning that confounding by surgeon and unit persists after weighting.

The statistics, in plain English

A relative risk of 0.62 with a confidence interval of 0.49 to 0.79 excludes 1.0 comfortably, so the association is not a chance finding. But the absolute difference is 0.15 percentage points — about 1 avoided injury for every 667 operations — which is what makes the intervention worth doing at scale and invisible in any single surgeon's practice. Inverse probability of treatment weighting balances measured confounders only; operative difficulty and surgeon judgement, the two variables that matter most here, are not in the dataset.

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