DNA/RNA-Based Next-Generation Sequencing Improves the Early Diagnosis and Management of Neoplastic Bile Duct Strictures: A 6-Year, Prospective, Multi-Institutional, Real-Time Study

Sep 22, 2026

BACKGROUND & AIMS: The distinction between benign and neoplastic bile duct strictures remains difficult, and pathology from ERCP specimens has limited sensitivity, especially in patients with primary sclerosing cholangitis. Next-generation sequencing of bile duct specimens is promising, but prospective, multi-institutional, comprehensive DNA/RNA analysis has been lacking. The study evaluates whether real-time, prospective DNA/RNA-based next-generation sequencing improves early diagnosis and management of neoplastic bile duct strictures through a 6-year, multi-institutional approach.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages32

Reading Time1 h 21 min

AccessFree to download

Abstract

Background & Aims

Study focus

Author Manuscript Author Manuscript Author Manuscript Author Manuscript | | HHS Public Access
Author manuscript
Gastroenterology. Author manuscript; available in PMC 2026 August 08. | | --- | --- | Published in final edited form as: Gastroenterology. 2026 August ; 171(2): 325–341. doi:10.1053/j.gastro.2026.02.040 . This is an open access article under the CC BY license ([http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)). Correspondence: Address correspondence to: Adam Slivka, MD, PhD, Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Pittsburgh Medicine Center, 200 Lothrop Street-PUH, M2, C Wing, Pittsburgh, Pennsylvania [15213. slivkaa@upmc.edu](15213. slivkaa@upmc.edu); or Nisa Kubiliun, MD, Division of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern, 1801 Inwood Road, 6th Floor, Suite 102, Dallas, Texas [75390. nisa.kubiliun@utsouthwestern.edu](75390. nisa.kubiliun@utsouthwestern.edu); or Aatur D. Singhi, MD, PhD, UPMC Presbyterian Hospital, 200 Lothrop Street, Room A616.2, Pittsburgh, Pennsylvania 15213. [singhiad@upmc.edu](singhiad@upmc.edu). CRediT Authorship Contributions Rohit Das, MD (Data curation: Equal; Formal analysis: Equal; Writing – original draft: Equal; Writing – review & editing: Equal) Jeffrey Kleinberger, MD PhD (Data curation: Equal; Formal analysis: Equal; Writing original draft: Equal; Writing – review & editing: Equal) Tarek Sawas, MD (Data curation: Equal; Formal analysis: Equal; Writing – original draft: Equal; Writing – review & editing: Equal) Abigail I. Wald, PhD (Data curation: Equal; Formal analysis: Equal; Writing – original draft: Equal; Writing – review & editing: Equal) Robert Bubar, MD (Data curation: Equal; Formal analysis: Equal) Harkirat Singh, MD (Data curation: Equal; Formal analysis: Equal) Jennifer Chennat, MD (Data curation: Equal; Formal analysis: Equal) Asif Khalid, MD (Data curation: Equal; Formal analysis: Equal) Stephanie L. Romutis, MD (Data curation: Equal; Formal analysis: Equal) Mordechai Rabinovitz, MD (Data curation: Equal; Formal analysis: Equal) Anna Tavakkoli, MD (Data curation: Equal; Formal analysis: Equal) Kimberly J. Fairley, DO (Data curation: Equal; Formal analysis: Equal) Brian A. Boone, MD (Data curation: Equal; Formal analysis: Equal) Savreet Sarkaria, MD (Data curation: Equal; Formal analysis: Equal) John Nasr, MD (Data curation: Equal; Formal analysis: Equal) Nikhil R. Thiruvengadam, MD (Data curation: Equal; Formal analysis: Equal) Charles Gabbert, MD (Data curation: Equal; Formal analysis: Equal) Sultan Mahmood, MD (Data curation: Equal; Formal analysis: Equal) Ahmed A. Messallam, MD (Data curation: Equal; Formal analysis: Equal) Mihajlo Gjeorgjievski, MD (Data curation: Equal; Formal analysis: Equal) Markus Goldschmiedt, MD (Data curation: Equal; Formal analysis: Equal) Shyam Thakkar, MD (Data curation: Equal; Formal analysis: Equal) Thomas Tielleman, MD (Data curation: Equal; Formal analysis: Equal) Mohannad Dugum, MD (Data curation: Equal; Formal analysis: Equal) Jon Reich, MD (Data curation: Equal; Formal analysis: Equal) Shailendra Singh, MD (Data curation: Equal; Formal analysis: Equal) Randall E. Brand, MD (Data curation: Equal; Formal analysis: Equal) Kevin McGrath, MD (Data curation: Equal; Formal analysis: Equal) Kenneth Fasanella, MD (Data curation: Equal; Formal analysis: Equal) Anne Marie Lennon, MD (Data curation: Equal; Formal analysis: Equal) Rekha Reddy, MD (Data curation: Equal; Formal analysis: Equal) Roshan Shrestha, MD (Data curation: Equal; Formal analysis: Equal) Daniel J. Ellis, MD (Data curation: Equal; Formal analysis: Equal) Sara A. Singhi, None (Data curation: Equal; Formal analysis: Equal) Terrence Lee, MD (Data curation: Equal; Formal analysis: Equal) Peter S. Kay, MD (Data curation: Equal; Formal analysis: Eq

FAQs

Why is distinguishing benign from neoplastic bile duct strictures challenging?

Because standard pathologic assessment of ERCP-obtained specimens has limited sensitivity, particularly for patients with primary sclerosing cholangitis.

What gap does the study address in bile duct specimen sequencing?

A prospective, multi-institutional, comprehensive DNA/RNA analysis had been lacking despite encouraging results from next-generation sequencing approaches.

What is the study design and duration?

A 6-year, prospective, multi-institutional, real-time study evaluating DNA/RNA-based next-generation sequencing for early diagnosis and management of neoplastic bile duct strictures.

Sep 22, 2026

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