CC BY 4.0 · Endoscopy
DOI: 10.1055/a-2619-6803
Original article

The value of Cholangioscopy-guided Bite-on-Bite (-on Bite) biopsies in Indeterminate Biliary Duct Strictures

1   Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, Netherlands
,
Pieter J.F. de Jonge
1   Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, Netherlands
,
1   Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, Netherlands
,
2   Clinic of Gastroenterology, Acibadem City Clinic University Hospital Tokuda, Sofia, Bulgaria
,
3   Endoscopy Unit, Gastroenterology Department, Hospital Universitario de Navarra. IdiSNA, Navarra Institute for Health Research, Pamplona, Spain
,
Ignacio Fernandez-Urien
3   Endoscopy Unit, Gastroenterology Department, Hospital Universitario de Navarra. IdiSNA, Navarra Institute for Health Research, Pamplona, Spain
,
Martin W James
4   NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, and School of Medicine, University of Nottingham, Nottingham, United Kingdom of Great Britain and Northern Ireland
,
Suresh Vasan Venkatachalapathy
4   NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, and School of Medicine, University of Nottingham, Nottingham, United Kingdom of Great Britain and Northern Ireland
,
5   Gastroenterology and Hepatology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom of Great Britain and Northern Ireland (Ringgold ID: RIN5983)
,
Andrea Anderloni
6   Gastroenterology and Digestive Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (Ringgold ID: RIN18631)
,
Alessandro Repici
7   Department of Biomedical Sciences, Humanitas University, Milano, Italy (Ringgold ID: RIN437807)
8   Endoscopy Unit, IRCCS Humanitas Research Hospital, Milano, Italy (Ringgold ID: RIN9268)
,
Roberto Gabbiadini
8   Endoscopy Unit, IRCCS Humanitas Research Hospital, Milano, Italy (Ringgold ID: RIN9268)
,
Deepak Joshi
9   Institute of Liver Studies, King’s College Hospital NHS Foundation Trust, London, United Kingdom of Great Britain and Northern Ireland
,
10   Interdisciplinary Endoscopy, Medical Department I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
,
Leena Kylänpää
11   Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland
,
Marianne Udd
11   Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland
,
Frans van der Heide
12   Gastroenterology and Hepatology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
,
13   Gastroenterology and Hepatology, University Hospital of Ghent, Ghent, Belgium
,
Gareth Corbett
14   Gastroenterology and Hepatology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom of Great Britain and Northern Ireland
,
14   Gastroenterology and Hepatology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom of Great Britain and Northern Ireland
,
Vincenzo Cennamo
15   Gastroenterology and Interventional Endoscopy Unit, Local Health Authority of Bologna, Bologna, Italy
,
Stefano Landi
15   Gastroenterology and Interventional Endoscopy Unit, Local Health Authority of Bologna, Bologna, Italy
,
16   Gastroenterology, University College London Hospitals, London, United Kingdom of Great Britain and Northern Ireland
,
George Webster
16   Gastroenterology, University College London Hospitals, London, United Kingdom of Great Britain and Northern Ireland
,
Marco J. Bruno
17   Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, Netherlands
› Author Affiliations
Clinical Trial: Registration number (trial ID): NL9649, Trial registry: Netherlands National Trial Register (http://www.trialregister.nl), Type of Study: Prospective

Background and study aims Digital single-operator cholangioscopy (d-SOC) has improved the diagnostic accuracy of indeterminate biliary duct strictures (IBDS) through targeted intra-ductal biopsy sampling. However, the optimal biopsy technique remains uncertain. Patients and methods: This international, multicenter, prospective interventional study (November 2020–August 2022) included IBDS patients undergoing d-SOC. 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 on pathology outcomes and one-year clinical follow-up. Primary outcome was the accuracy of both biopsy techniques. Results Eighty-nine patients were included, of which 52 had hilar and 37 distal strictures. Technical success rates for single biopsies and BBB were 82/89 (92.1%) and 78/89 (87.6%), respectively. Malignancy was confirmed in 31/82 (37.8%) and 29/78 (37.2%) cases in single biopsies and BBB, respectively. Among 76 cases in whom both techniques were successful, pathology results were discordant in three (3.9%) cases, primarily due to under staging by BBB. Among 82 patients with complete follow-up, malignancy was confirmed in 51 (62.2%) patients. 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 intra-ductal tissue acquisition at a prior ERCP. The number of BBB 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.



Publication History

Received: 25 September 2024

Accepted after revision: 20 May 2025

Accepted Manuscript online:
23 May 2025

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