Sjögren's disease & overlap diseases
Length-based adequacy thresholds for submandibular gland core needle biopsy in suspected Sjögren's disease: two-phase study
Authors' conclusion
A CNB specimen length of ≥7.6 mm is sufficient for diagnosing SjD, while ≥10.5 mm may be required for clinical trials.
Study context
- Population
- Consecutive patients undergoing US-guided submandibular gland core needle biopsy (CNB) with an 18-gauge needle for suspicious chronic inflammatory sialadenitis (suspected Sjögren's disease (SjD))validation cohort n=37
- Participants
- 119 patients
- Comparison
- 7.6 mm threshold vs 10.5 mm threshold
- Outcome
- Optimal CNB specimen length thresholds for adequate glandular surface area
Methodological detailsretrospective, dual-phase, consecutive patients, validation cohort
- Retrospective
- Dual-phase
- Consecutive patients
- Validation cohort
Performance
As reported in the abstract
Specimen length thresholds for glandular surface area (ROC analysis)
- Specimen length correlated with glandular surface area (ρ)
- 0.69, p<0.001
- Specimen length a positive predictor of glandular surface area (multivariable)
- p<0.001
- Fatty infiltration a negative predictor of glandular surface area (multivariable)
- p=0.003
- Optimal threshold for glandular surface area ≥4 mm²
- 7.6 mm
- Optimal threshold for glandular surface area ≥8 mm²
- 10.5 mm
Further findings
Threshold performance in the validation cohort
PPV
NPV
- Threshold performance in the validation cohort: validation cohort (n=37)
Safety
Clinically significant haematomas
- Proportion of cases
- 1.7%
Original publication
Length-based adequacy thresholds for submandibular gland core needle biopsy in suspected Sjögren's disease: two-phase study. Clin Exp Rheumatol. Published 26 July 2025. doi:10.
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