Background and Aims
Pathologic evaluation of bile duct lesions is crucial for a definitive diagnosis and
determination of an appropriate therapeutic strategy; however, current methods are
limited by several challenges. This study evaluated the impact of a novel tapered-tip
sheath system on biliary stricture diagnosis.
Methods
This observational study evaluated 47 consecutive patients who underwent transpapillary
biliary stricture biopsy using the novel tapered-tip sheath system from July 2020
to March 2022 compared with 51 historical control subjects undergoing conventional
biopsies. Technical success rate, total biopsy time, number of biopsy specimens, adequate
tissue sampling rate, adverse events, and diagnostic performance for biliary strictures
were assessed.
Results
The technical success rate was favorable in both groups, showing no significant difference
(97.9% [46 of 47] vs 88.2% [45 of 51], P = .114). However, the total biopsy time was significantly shorter in the novel system
group (3.7 vs 7.7 minutes, P < .001). The number of biopsy specimens did not differ between the groups; however,
the novel system group had significantly more cases in which ≥3 tissue samples could
be obtained (71.7% [33 of 46] vs 51.1% [23 of 45], P = .043), a higher adequate tissue sampling rate (88.2% vs 66.4%, P < .001), and fewer adverse events (6.4% vs 21.6%, P = .043). Although the diagnostic specificity of both groups was 100%, the novel system
group had significantly higher diagnostic sensitivity and accuracy (82.1% vs 50% [P = .004] and 84.8% vs 55.5% [P = .005], respectively).
Conclusions
The novel tapered-tip sheath system is a promising tool for biliary stricture diagnosis.
Abbreviations:
EST (endoscopic sphincterotomy), IDUS (intraductal ultrasound), PEP (post-ERCP pancreatitis), POCS (peroral cholangioscopy)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: February 10, 2023
Accepted:
February 6,
2023
Received:
August 30,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
DISCLOSURE: All authors disclosed no financial relationships.
DIVERSITY, EQUITY, AND INCLUSION: We worked to ensure gender balance in the recruitment of human subjects. We worked to ensure ethnic or other types of diversity in the recruitment of human subjects. We worked to ensure that the language of the study questionnaires reflected inclusion. We worked to ensure sex balance in the selection of non-human subjects.
Identification
Copyright
© 2023 by the American Society for Gastrointestinal Endoscopy
