Abstract
Objective
Bleeding after endoscopic submucosal dissection (ESD) for early gastric cancer
(EGC) is a frequent adverse event after ESD. We aimed to develop and externally
validate a clinically useful prediction model (BEST-J score: Bleeding after ESD Trend
from Japan) for bleeding after ESD for EGC.
Design
This retrospective study enrolled patients who underwent ESD for EGC. Patients
in the derivation cohort (n=8291) were recruited from 25 institutions, and patients in
the external validation cohort (n=2029) were recruited from eight institutions in
other areas. In the derivation cohort, weighted points were assigned to predictors of
bleeding determined in the multivariate logistic regression analysis and a prediction
model was established. External validation of the model was conducted to analyse
discrimination and calibration.
Results
A prediction model comprised 10 variables (warfarin, direct oral anticoagulant,
chronic kidney disease with haemodialysis, P2Y12 receptor antagonist, aspirin,
cilostazol, tumour size >30 mm, lower-third in tumour location, presence of
multiple tumours and interruption of each kind of antithrombotic agents). The rates of
bleeding after ESD at low-risk (0 to 1 points), intermediate-risk (2 points),
high-risk (3 to 4 points) and very high-risk (≥5 points) were 2.8%, 6.1%, 11.4% and
29.7%, respectively. In the external validation cohort, the model showed moderately
good discrimination, with a c-statistic of 0.70 (95% CI,
0.64 to 0.76), and good calibration (calibration-in-the-large, 0.05; calibration
slope, 1.01).
Conclusions
In this nationwide multicentre study, we derived and externally validated a
prediction model for bleeding after ESD. This model may be a good clinical
decision-making support tool for ESD in patients with EGC.
Funder
The Japanese
Foundation for Research and Promotion of Endoscopy Grant