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  • 1. Aims and Scope

    Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut atnd Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology. +MORE

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    Editor-in-Chief
    Yong Chan Lee Professor of Medicine
    Director, Gastrointestinal Research Laboratory
    Veterans Affairs Medical Center, Univ. California San Francisco
    San Francisco, USA

    Deputy Editor

    Deputy Editor
    Jong Pil Im Seoul National University College of Medicine, Seoul, Korea
    Robert S. Bresalier University of Texas M. D. Anderson Cancer Center, Houston, USA
    Steven H. Itzkowitz Mount Sinai Medical Center, NY, USA
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    All papers submitted to Gut and Liver are reviewed by the editorial team before being sent out for an external peer review to rule out papers that have low priority, insufficient originality, scientific flaws, or the absence of a message of importance to the readers of the Journal. A decision about these papers will usually be made within two or three weeks.
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Diagnosis of Intraductal Biliary Lesions: Towards Greater Accuracy and Safety

Sung Woo Ko , Seung Bae Yoon

Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea

Correspondence to: Seung Bae Yoon
ORCID https://orcid.org/0000-0002-6119-7236
E-mail sbyoon@catholic.ac.kr

See “Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial” by Hirokazu Okada, et al. on page 136, Vol. 19, No. 1, 2025

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Gut Liver 2025;19(1):6-7. https://doi.org/10.5009/gnl240592

Published online January 15, 2025, Published date January 15, 2025

Copyright © Gut and Liver.

Biliary strictures represent a considerable diagnostic challenge, particularly in differentiating benign from malignant lesions, even after thorough and extensive diagnostic evaluation. Delayed or inaccurate diagnosis of malignant lesions can lead to missed opportunities for timely and potentially life-saving treatment. Conversely, failing to accurately identify benign cases may result in unnecessary and invasive interventions, such as liver resection, which carry their own risks and complications.

A conventional first-line method for obtaining a tissue diagnosis in patients with intraductal biliary lesions is endoscopic retrograde cholangiopancreatography (ERCP)-guided brush cytology, though this technique is significantly limited by its low sensitivity.1 Peroral cholangioscopy-guided biopsy is a viable alternative; however, its clinical utility is constrained by the need for advanced technical expertise, significant procedural costs, and the platform's design limitation, which accommodates only dedicated small-caliber forceps.2 Furthermore, in malignant cases where systemic therapies, such as chemotherapy, are under consideration, adequate tissue sampling for genomic profiling is now strongly advised. Previous meta-analysis has emphasized that achieving sufficient diagnostic accuracy for malignant biliary lesions requires a multimodal approach, recommending the combined use of intraductal brushing, forceps biopsy, and endoscopic ultrasound-guided fine-needle aspiration to improve diagnostic yield.3

At the same time, it is essential to acknowledge and carefully evaluate the potential adverse events associated with procedures for obtaining biliary tissue samples. Advanced techniques, such as ERCP-guided intraductal forceps biopsy via the transpapillary approach, inherently carry risks of complications, including post-ERCP pancreatitis (PEP), hemorrhage, and biliary perforation. Similarly, peroral cholangioscopy-guided biopsy is also associated with a notable risk of procedural complications, underscoring the need for caution. Therefore, when performing tissue sampling from the bile duct, clinicians must balance the dual considerations of efficacy and safety to ensure optimal patient outcomes.

In the current issue of Gut and Liver, Okada et al.4 conducted a randomized controlled trial to assess and compare the efficacy and safety of a novel tapered-tip sheath system with the conventional method for biliary lesion tissue sampling. The novel method achieved technical success in 96.0% (24/25) of cases, compared to only 48.0% (12/25) with the conventional method. Adverse event rates were similarly favorable, occurring in just 4.0% (1/25) of patients in the novel sheath group versus 36.0% (9/25) in the conventional group. These findings highlight the statistical superiority of the novel sheath system in terms of both diagnostic efficacy and procedural safety. The novel tapered-tip sheath system demonstrated the capability to deliver forceps to biliary lesions without requiring endoscopic sphincterotomy (EST), effectively minimizing complications and improving diagnostic accuracy regardless of the lesion’s location. This prospective trial successfully validated the clinical potential of this innovative device, which had previously been suggested based on retrospective studies conducted by the same authors.5,6

However, several critical considerations must be considered when interpreting the findings of this study. First, the success rate of the conventional method appears disproportionately low. While the study focuses on tissue sampling without prior EST, reporting a success rate below 50%, it is important to recognize that in most clinical settings, EST is routinely performed before interventions such as tissue sampling or stent placement, which likely improves procedural success. Second, this study was conducted at a single institution, which inherently limits the generalizability of its findings. To ensure broader applicability and acceptance, further validation through well-designed multicenter studies is essential. Third, the results demonstrated a markedly elevated incidence of PEP with the conventional method in comparison to the novel method. Nevertheless, it remains unclear whether the discrepancy in pancreatitis rates is exclusively attributable to the biopsy method or if demographic risk factors for PEP, such as sex and age, contributed to this disparity. Finally, it remains crucial to evaluate whether the novel method can consistently provide sufficient tissue for genomic profiling, which is a key requirement for advancing precision medicine beyond basic diagnostic purposes.

To date, several efforts have been made to enhance the diagnostic yield of ERCP-guided biliary tissue sampling using forceps; however, most devices have failed to achieve global commercialization and adoption for routine clinical use.7,8 The integration of this newly developed device into the routine clinical practice of endoscopists remains uncertain. Further validation through future multicenter clinical trials, along with efforts to enhance its clinical utility and accessibility, is anticipated to clarify its role and contribute to advancements in the field.

No potential conflict of interest relevant to this article was reported.

  1. Korc P, Sherman S. ERCP tissue sampling. Gastrointest Endosc 2016;84:557-571.
    Pubmed CrossRef
  2. Parsa N, Khashab MA. The role of peroral cholangioscopy in evaluating indeterminate biliary strictures. Clin Endosc 2019;52:556-564.
    Pubmed KoreaMed CrossRef
  3. Yoon SB, Moon SH, Ko SW, Lim H, Kang HS, Kim JH. Brush cytology, forceps biopsy, or endoscopic ultrasound-guided sampling for diagnosis of bile duct cancer: a meta-analysis. Dig Dis Sci 2022;67:3284-3297.
    Pubmed CrossRef
  4. Okada H, Uza N, Matsumori T, et al. Efficacy and safety of a novel tapered-tip sheath system for biliary-lesion tissue sampling: a randomized controlled trial. Gut Liver 2025;19:136-144.
    Pubmed CrossRef
  5. Matsumori T, Uza N, Shiokawa M, et al. Clinical impact of a novel device delivery system in the diagnosis of bile duct lesions: a single-center experience. J Gastroenterol Hepatol 2022;37:1360-1366.
    Pubmed CrossRef
  6. Matsumori T, Uza N, Okada H, et al. Innovative method for the diagnosis of bile duct lesions using a novel tapered-tip sheath system to facilitate biliary biopsies. Gastrointest Endosc 2023;98:43-50.
    Pubmed CrossRef
  7. Hamada T, Takahara N, Nakai Y, Kanai S, Saito T, Koike K. The "zipline" technique for endoscopic transpapillary biliary biopsy. Endoscopy 2020;52:236-237.
    Pubmed CrossRef
  8. Ko SW, Lee SS, So H, et al. A novel method of biopsy for indeterminate pancreaticobiliary strictures: tube-assisted biopsy. Endoscopy 2020;52:589-594.
    Pubmed CrossRef

Article

Editorial

Gut and Liver 2025; 19(1): 6-7

Published online January 15, 2025 https://doi.org/10.5009/gnl240592

Copyright © Gut and Liver.

Diagnosis of Intraductal Biliary Lesions: Towards Greater Accuracy and Safety

Sung Woo Ko , Seung Bae Yoon

Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea

Correspondence to:Seung Bae Yoon
ORCID https://orcid.org/0000-0002-6119-7236
E-mail sbyoon@catholic.ac.kr

See “Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial” by Hirokazu Okada, et al. on page 136, Vol. 19, No. 1, 2025

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Body

Biliary strictures represent a considerable diagnostic challenge, particularly in differentiating benign from malignant lesions, even after thorough and extensive diagnostic evaluation. Delayed or inaccurate diagnosis of malignant lesions can lead to missed opportunities for timely and potentially life-saving treatment. Conversely, failing to accurately identify benign cases may result in unnecessary and invasive interventions, such as liver resection, which carry their own risks and complications.

A conventional first-line method for obtaining a tissue diagnosis in patients with intraductal biliary lesions is endoscopic retrograde cholangiopancreatography (ERCP)-guided brush cytology, though this technique is significantly limited by its low sensitivity.1 Peroral cholangioscopy-guided biopsy is a viable alternative; however, its clinical utility is constrained by the need for advanced technical expertise, significant procedural costs, and the platform's design limitation, which accommodates only dedicated small-caliber forceps.2 Furthermore, in malignant cases where systemic therapies, such as chemotherapy, are under consideration, adequate tissue sampling for genomic profiling is now strongly advised. Previous meta-analysis has emphasized that achieving sufficient diagnostic accuracy for malignant biliary lesions requires a multimodal approach, recommending the combined use of intraductal brushing, forceps biopsy, and endoscopic ultrasound-guided fine-needle aspiration to improve diagnostic yield.3

At the same time, it is essential to acknowledge and carefully evaluate the potential adverse events associated with procedures for obtaining biliary tissue samples. Advanced techniques, such as ERCP-guided intraductal forceps biopsy via the transpapillary approach, inherently carry risks of complications, including post-ERCP pancreatitis (PEP), hemorrhage, and biliary perforation. Similarly, peroral cholangioscopy-guided biopsy is also associated with a notable risk of procedural complications, underscoring the need for caution. Therefore, when performing tissue sampling from the bile duct, clinicians must balance the dual considerations of efficacy and safety to ensure optimal patient outcomes.

In the current issue of Gut and Liver, Okada et al.4 conducted a randomized controlled trial to assess and compare the efficacy and safety of a novel tapered-tip sheath system with the conventional method for biliary lesion tissue sampling. The novel method achieved technical success in 96.0% (24/25) of cases, compared to only 48.0% (12/25) with the conventional method. Adverse event rates were similarly favorable, occurring in just 4.0% (1/25) of patients in the novel sheath group versus 36.0% (9/25) in the conventional group. These findings highlight the statistical superiority of the novel sheath system in terms of both diagnostic efficacy and procedural safety. The novel tapered-tip sheath system demonstrated the capability to deliver forceps to biliary lesions without requiring endoscopic sphincterotomy (EST), effectively minimizing complications and improving diagnostic accuracy regardless of the lesion’s location. This prospective trial successfully validated the clinical potential of this innovative device, which had previously been suggested based on retrospective studies conducted by the same authors.5,6

However, several critical considerations must be considered when interpreting the findings of this study. First, the success rate of the conventional method appears disproportionately low. While the study focuses on tissue sampling without prior EST, reporting a success rate below 50%, it is important to recognize that in most clinical settings, EST is routinely performed before interventions such as tissue sampling or stent placement, which likely improves procedural success. Second, this study was conducted at a single institution, which inherently limits the generalizability of its findings. To ensure broader applicability and acceptance, further validation through well-designed multicenter studies is essential. Third, the results demonstrated a markedly elevated incidence of PEP with the conventional method in comparison to the novel method. Nevertheless, it remains unclear whether the discrepancy in pancreatitis rates is exclusively attributable to the biopsy method or if demographic risk factors for PEP, such as sex and age, contributed to this disparity. Finally, it remains crucial to evaluate whether the novel method can consistently provide sufficient tissue for genomic profiling, which is a key requirement for advancing precision medicine beyond basic diagnostic purposes.

To date, several efforts have been made to enhance the diagnostic yield of ERCP-guided biliary tissue sampling using forceps; however, most devices have failed to achieve global commercialization and adoption for routine clinical use.7,8 The integration of this newly developed device into the routine clinical practice of endoscopists remains uncertain. Further validation through future multicenter clinical trials, along with efforts to enhance its clinical utility and accessibility, is anticipated to clarify its role and contribute to advancements in the field.

CONFLICTS OF INTEREST

No potential conflict of interest relevant to this article was reported.

References

  1. Korc P, Sherman S. ERCP tissue sampling. Gastrointest Endosc 2016;84:557-571.
    Pubmed CrossRef
  2. Parsa N, Khashab MA. The role of peroral cholangioscopy in evaluating indeterminate biliary strictures. Clin Endosc 2019;52:556-564.
    Pubmed KoreaMed CrossRef
  3. Yoon SB, Moon SH, Ko SW, Lim H, Kang HS, Kim JH. Brush cytology, forceps biopsy, or endoscopic ultrasound-guided sampling for diagnosis of bile duct cancer: a meta-analysis. Dig Dis Sci 2022;67:3284-3297.
    Pubmed CrossRef
  4. Okada H, Uza N, Matsumori T, et al. Efficacy and safety of a novel tapered-tip sheath system for biliary-lesion tissue sampling: a randomized controlled trial. Gut Liver 2025;19:136-144.
    Pubmed CrossRef
  5. Matsumori T, Uza N, Shiokawa M, et al. Clinical impact of a novel device delivery system in the diagnosis of bile duct lesions: a single-center experience. J Gastroenterol Hepatol 2022;37:1360-1366.
    Pubmed CrossRef
  6. Matsumori T, Uza N, Okada H, et al. Innovative method for the diagnosis of bile duct lesions using a novel tapered-tip sheath system to facilitate biliary biopsies. Gastrointest Endosc 2023;98:43-50.
    Pubmed CrossRef
  7. Hamada T, Takahara N, Nakai Y, Kanai S, Saito T, Koike K. The "zipline" technique for endoscopic transpapillary biliary biopsy. Endoscopy 2020;52:236-237.
    Pubmed CrossRef
  8. Ko SW, Lee SS, So H, et al. A novel method of biopsy for indeterminate pancreaticobiliary strictures: tube-assisted biopsy. Endoscopy 2020;52:589-594.
    Pubmed CrossRef
Gut and Liver

Vol.19 No.1
January, 2025

pISSN 1976-2283
eISSN 2005-1212

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