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Multicenter Study
. 2025 Nov;57(11):1220-1229.
doi: 10.1055/a-2619-6803. Epub 2025 May 23.

The value of cholangioscopy-guided bite-on-bite (-on bite) biopsies in indeterminate biliary duct strictures

David M de Jong  1 , Pieter Jan F de Jonge  1 , Pauline M C Stassen  1 , Petko Karagyozov  2 , Juan J Vila  3 , Ignacio Fernández-Urién  3 , Martin W James  4 , Suresh V Venkatachalapathy  4 , Kofi W Oppong  5 , Andrea Anderloni  6 , Alessandro Repici  7   8 , Roberto Gabbiadini  7 , Deepak Joshi  9 , Mark Ellrichmann  10 , Leena Kylänpää  11 , Marianne Udd  11 , Frans van der Heide  12 , Pieter Hindryckx  13 , Gareth Corbett  14 , Kirill Basiliya  14 , Vincenzo Cennamo  15 , Stefano Landi  15 , Simon Phillpotts  16 , George J Webster  16 , Marco J Bruno  1 ; European Cholangioscopy Group
Affiliations
Multicenter Study

The value of cholangioscopy-guided bite-on-bite (-on bite) biopsies in indeterminate biliary duct strictures

David M de Jong et al. Endoscopy. 2025 Nov.

Abstract

Background: Digital single-operator cholangioscopy (dSOC) has improved the diagnostic accuracy of indeterminate biliary duct strictures (IBDS) through targeted intraductal biopsy sampling. However, the optimal biopsy technique remains uncertain.

Methods: This international, multicenter, prospective interventional study (November 2020-August 2022) included patients with IBDS undergoing dSOC. Stricture sampling involved obtaining at least four single biopsies and at least one bite-on-bite biopsy (BBB) in all patients. Definitive diagnosis was established by pathology outcomes and 1-year clinical follow-up. The primary outcome was the accuracy of both biopsy techniques.

Results: 89 patients were included, with 76 hilar strictures and 13 distal strictures. Technical success for obtaining adequate tissue samples was 82/89 (92.1 %) for single biopsies and 78/89 (87.6 %) for BBB. Malignancy was confirmed in 31/82 (37.8 %) and 29/78 (37.2 %) cases in single biopsies and BBB, respectively. Among 76 patients in whom both techniques were successful, pathology results were discordant in three cases (3.9 %), primarily due to understaging by BBB. Among 82 patients with complete follow-up, malignancy was confirmed in 51 (62.2 %). Sensitivity, specificity, and accuracy for malignancy or high grade dysplasia were 66.0 %, 100 %, and 78.8 % for single biopsies, and 63.8 %, 100 %, and 77.6 % for BBB, respectively. Sensitivity and accuracy were significantly decreased after stent placement or intraductal tissue acquisition during prior ERCP. The number of BBBs did not impact sensitivity or accuracy.

Conclusions: BBB did not outperform at least four single biopsies for IBDS. Prior manipulation of IBDS, through stent placement or prior tissue acquisition, was associated with a decreased diagnostic yield.

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Conflict of interest statement

P.J.F. de Jonge is a speaker for and has received a consultancy fee from Boston Scientific. J.J. Vila is a speaker for Pentax, Cook Medical, and Olympus, and a consultant for Boston Scientific. M.W. James has received consultancy fees from Boston Scientific and Cook Medical. K.W. Oppong has received research funding for investigator-initiated studies from Medtronic, and has received speaker fees from Medtronic and Boston Scientific. A. Anderloni is a consult and speaker for Boston Scientific, Olympus, and Q3 Medical. D. Joshi is a speaker for and has received consultancy fees from Boston Scientific, Cook Medical, Ipsen Pharmaceutical, Mirum Pharmaceuticals, and Q3 Medical. M. Ellrichmann has received research funding for industry-initiated studies from Boston Scientific, and for investigator-initiated trials from Boston Scientific; he is also a consultant for Boston Scientific, Microtech, Medwork, and Olympus. L. Kylänpää has received speaker fees from Boston Scientific. F. van der Heide has received speaker fees from AbbVie. P. Hindryckx is a speaker for and has received consultancy fees from Medtronic, Boston Scientific, Viatris, Fujifilm, and Medwork. V. Cennamo is a consultant and speaker for and has received travel grants from Olympus Italia, Olympus Europe, and Euromedical. G.J.M. Webster is a consultant and speaker for Boston Scientific, Cook Medical, Pentax Medical, and Olympus Europe. M.J. Bruno has received research funding for industry-initiated studies from Boston Scientific and Cook Medical, and for investigator-initiated studies from Boston Scientific, Cook Medical, Pentax Medical, Interscope, Mylan, and ChiRoStim; he is also a consultant for Boston Scientific, Cook Medical, and Pentax Medical. D.M. de Jong, P.M.C. Stassen, P. Karagyozov, I. Fernandez-Urien, S.V. Venkatachalapathy, A. Repici, R. Gabbiadini, M. Udd, G. Corbett, K. Basiliya, S. Landi, and S. Phillpotts declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Three examples of indeterminate biliary duct strictures with digital single-operator cholangioscopy. a A perihilar stricture. Multiple single biopsies showed benign disease, while bite-on-bite biopsy (BBB) yielded inadequate tissue. Finally, endoscopic ultrasound-guided biopsy confirmed the suspicion of perihilar cholangiocarcinoma. b A distal stricture located at the insertion of the cystic duct. Both single and BBB biopsies were inconclusive. Surgical resection confirmed chronic segmental sclerosing cholangitis. c A perihilar stricture. Both single and BBB biopsies were suspicious for malignancy.
Fig. 2
Fig. 2
Flow chart of included patients. *All five patients with < 4 single biopsies had adequate specimens.
See this image and copyright information in PMC

References

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