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OUTCOMES OF PATIENTS WITH INDETERMINATE BILIARY STRICTURES FOLLOWING COMPREHENSIVE ENDOSCOPIC WORKUP
Andrew Kleehammer
*1, Matthew Giansiracusa
1, Sean Olson
1, Lindsey Creech
1, Tayna D. Latortue
1, Tiffany Y. Chua
1, Jennifer Fieber
2, Chris Forsmark
1, Aleksey A. Novikov
11Gastroenterology, University of Florida, Gainesville, FL; 2Surgery, University of Florida, Gainesville, FL
Intro
Indeterminate biliary strictures (IS) are recognized as strictures that lack a malignancy diagnosis after endoscopic workup. IS are historically associated with occult pancreatico-biliary malignancy. This association often prompts invasive surgery for what is found to be benign disease. This study aimed to analyze modern outcomes of patients with IS and factors that may predict malignancy.
Methods
We identified 531 patients who underwent ERCP and EUS from 2020-2024 at our institution. Those with no obvious mass on cross-sectional imaging and no diagnosis after initial internal EUS and ERCP were included in the study. We collected demographics, information regarding EUS and ERCP tissue sampling maneuvers, liver chemistries and CA-19-9 at index procedure, length of follow-up, final diagnosis of malignancy, and additional advanced therapies. Continuous variables were reported as means with 95% confidence interval, categorical variables were reported as percentages and fractions. Data analysis was performed using Stata 16.1 (College Station, Tx).
Results
We identified 60 patients with IS. Final diagnosis of malignancy was made in 41.67% (25/60) of patients. 15% (9/60) of patients with IS were lost to follow-up (defined as no patient encounter within 3 months of final review). Median follow-up was 412 days. Mean age was 61.1 years (56.4-65.4) in those without malignancy versus 69.7 years (64.2-75.1) for those with malignancy, p< 0.02. Although liver chemistries were higher in malignancy-present cases, none reached statistical significance. Median CA 19-9 levels were higher in malignancy-present cases at 199.5 U/mL (68.5–148) than in malignancy-absent cases 78.5 U/mL (16–369); however this was not statistically significant (p=0.20). (Table).
The median number of EUS was 2 (1–2) for those diagnosed with malignancy and 1 (1–2) for those without malignancy (p=0.03). The number of ERCPs showed no significant difference with a median of 2 (IQR: 1–3) for both groups (p=0.56). Importantly, bile duct specific next generation sequencing (NGS) testing was associated with patients who ended up having malignancy, (p=0.003). (Table).
Outcomes of diagnostic sampling modalities are summarized in the Figure. Cytology brushing had the lowest positive rate at 1.67% (1/60) and EUS biopsies had the highest probability of success at 22.6% (7/31) (Figure). Among patients who did not develop malignancy 8.57% (3/35) had pancreatic surgery, 2.86% (1/35) had chemotherapy, and 2.86%(1/35) had radiation therapy. Among malignant cases 20.0% (5/25) had pancreatic surgery, 60.0% (15/25) had chemotherapy, and 20.0% (5/25) had radiation therapy.
Conclusions
In patients with IS, the use of bile duct specific NGS can be beneficial in the diagnostic workup for occult malignancy. More endoscopic ultrasound procedures were also associated with increased odds of malignancy diagnosis.
Table
Figure
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