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BILE LIQUID BIOPSY IN PANCREATOBILIARY TUMORS: A NOVEL APPROACH TO DETECT ACTIONABLE MUTATIONS

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BILE LIQUID BIOPSY IN PANCREATOBILIARY TUMORS: A NOVEL APPROACH TO DETECT ACTIONABLE MUTATIONS

Javier Rández-Garbayo 1, Maria Rullan Iriarte 2, Diary Fall 3, Silvia Pinto Martínez 2, Patricia de Miguel 2, David Ruiz-Clavijo Garcia 2, Belen GONZÁLEZ DE LA HIGUERA CARNICER 2, Federico Bolado Concejo 2, Daniel Oyón 4, Irene Amat 2, David Guerrero-Setas 2, Ana Purroy 1, Juan Carrascosa Gil 2, Vanesa Jusué Irurita 2, Ignacio Fernández-Urién Sainz 2, María Arechederra 5, Carmen Berasain 5, Juan Jose Vila 2, Matias A. Avila 5, Jesús M. Urman 2

Affiliations

1 Navarrabiomed, Pamplona, Spain|||Navarra Institute for Health Research, IdiSNA, Pamplona, Spain

2 Navarra University Hospital, Pamplona, Spain|||Navarra Institute for Health Research, IdiSNA, Pamplona, Spain

3 Navarra University Hospital, Pamplona, Spain

4 Hospital General Universitario Gregorio Marañón, Madrid, Spain|||Navarra Institute for Health Research, IdiSNA, Pamplona, Spain

5 Center of Applied Medicine (CIMA) / University of Navarra, Pamplona, Spain|||Navarra Institute for Health Research, IdiSNA, Pamplona, Spain

Summary

AI Generated

NGS-based cell-free DNA analysis of bile collected during ERCP detected actionable mutations in 37% of cholangiocarcinoma patients and 55% of pancreatic cancer patients with biliary stenosis, outperforming tissue NGS in this 28-patient proof-of-concept study.

In 19 cholangiocarcinoma patients, bile NGS identified 7 patients (37%) with actionable mutations (ERBB2, IDH2, KRAS^G12C) versus none detected in tissue NGS, and detected 47/49 total mutations versus 22/49 in tissue.
In 9 pancreatic cancer patients, bile NGS identified 5 patients (55%) with actionable mutations versus 4 (44%) in tissue, detecting 16/18 mutations versus 12/18 in tissue.
Bile NGS identified all 19 cholangiocarcinoma patients with mutations (100%) compared to 84.3% (16/19) by tissue NGS, with 91% concordance for mutations detected in both sources.
Bile samples were collected during the first prescribed ERCP using a 52-gene panel, while tissue samples required at least 40% tumor content and were analyzed with a 161-gene panel.
The approach does not consume histological material, and bile collection during standard ERCP for biliary drainage is described as simple and secure.

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Abstract

Introduction

Biliary strictures are usually caused by malignancies such as Cholangiocarcinoma (CCA) or Pancreatic Ductal Adenocarcinoma (PDAC). 70% of these neoplasms are diagnosed at advanced stages due to late-onset symptoms, lack of biomarkers, and challenges in obtaining histological samples. Curative surgical resection with adjuvant therapy is the first-line treatment, but 20% of cases are resectable at diagnosis and 80% relapse within 3 years^1,2. The impact of systemic therapies on overall survival remains limited, however new targeted therapies have shown remarkable efficacy in patients with actionable mutations based on tumor genetic profiling. Clinical guidelines advocate multigene panel analysis of tumor tissue prior to or during first-line treatment^3,4, considering that 40% of CCA patients and around 25% of PDAC patients harbor actionable genetic mutations^5,6. When tumor tissue is insufficient, liquid biopsies using cfDNA can be considered³. Liquid biopsy of bile, collected during an Endoscopic Retrograde Cholangiopancreatography (ERCP) in malignant biliary stricture cases, could potentially detect therapeutic targets.

Aims & Methods

This prospective proof-of-concept pilot study aims to assess NGS-based cfDNA analysis in bile as a novel liquid biopsy for detecting genetic mutations, and specifically actionable mutations, compared to tissue NGS.
19 CCA and 9 PDAC patients with malignant biliary stenosis undergoing ERCP in a tertiary hospital (2017-2020) were included. Bile samples were collected during the first ERCP and the Pathological Anatomy department selected tissue samples with ≥40% tumor content. Massive sequencing of DNA libraries was performed using the Pan-Cancer Panel^TM (52-genes) for bile samples, and the Oncomine^TM Comprehensive Assay Panel v3 (161 genes) for tissue.

Results

Concerning CCA patients, bile NGS identified all patients with mutations (19/19) opposite to 84.3% (16/19) of patients in tissue. Bile NGS identified 7 patients (37%) with actionable mutations, none was detected in tissue. We detected 47/49 mutations in bile NGS vs. 22/49 in tissue. High concordance was observed: 91% (20/22) of tissue mutations were also in bile. Regarding actionable mutations considered in ESMO guidelines³; 7 were detected in bile NGS, none detected in tissue. The actionable mutations identified were ERBB2 (5), IDH2 (1), and KRAS^G12C(1).
In the PDAC group, bile NGS identified 89% (8/9) of patients with mutations, compared to 66.6% (6/9) of patients in tissue. Bile NGS identified 5 patients (55%) with actionable mutations vs. 4 (44%) in tissue. Bile NGS detected 16/18 mutations in bile in contrast to 12/18 in tissue. High concordance was observed: 83.3% (10/12) of tissue mutations were also in bile. NGS in bile detected 6 actionable mutations considered in ESMO guidelines^4,; KRAS^G12D (5) and ERBB3, compared to 4 in tissue; KRAS^G12D.

Conclusion

These results highlight the potential of bile liquid biopsy in detecting actionable mutations; bile NGS increased the diagnosis sensibility and the number of mutations detected, compared with tissue NGS, which could allow more patients to be considered for targeted therapies. This approach does not require histological material consumption and collecting bile during an ERCP is simple and secure. In addition, NGS technology is available in all molecular laboratories. We consider that the application of liquid biopsy in bile can be accessible and an effective tool, with direct and immediate clinical implementation, improving precision medicine strategies and the therapeutic management of CCA and PDAC patients with biliary stenosis.

References

1. Banales JM, Marin JJG, Lamarca A, Rodrigues PM, Khan SA, Roberts LR, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020 Sep;17(9):557-588. Epub 2020 Jun 30.
2.Park W, Chawla A, O’Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851–62.3.
3.Vogel A, Ducreux M; ESMO Guidelines Committee. ESMO Clinical Practice Guideline interim update on the management of biliary tract cancer. ESMO Open. 2025 Jan;10(1):104003. Epub 2024 Dec 17.
4.Conroy T, Pfeiffer P, Vilgrain V, Lamarca A, Seufferlein T, O’Reilly EM, et al. Pancreatic cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Nov;34(11):987–1002.
5. Gilbert TM, Randle L, Quinn M, McGreevy O, O'leary L, Young R, et al. Molecular biology of cholangiocarcinoma and its implications for targeted therapy in patient management. Eur J Surg Oncol. 2025 Feb;51(2):108352. Epub 2024 Apr 17
6. Boileve A, Smolenschi C, Lambert A, Boige V, Tarabay A, Valery M, et al. Role of molecular biology in the management of pancreatic cancer. World J Gastrointest Oncol. 2024 Jul 15;16(7):2902-2914.

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Immunology Pancreas Surgery Hepatobiliary

Submission format

Abstract

Session

PDAC surveillance and treatment: The how's and why's

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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HCC: Novel treatment options in advanced diseases

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HCC: Novel treatment options in advanced diseases

Najib Ben Khaled 1

Affiliations

1 LMU Munich, Munich, Germany

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Abstract

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Hepatobiliary Mechanisms & Personalised Medicine Radiology & Imaging

Session

Advancement in management of primary liver tumors

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Pancreas necrosis: What to do after initial drainage

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Pancreas necrosis: What to do after initial drainage

Robert C. Verdonk 1

Affiliations

1 St. Antonius Ziekenhuis, Nieuwegein, Netherlands

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Abstract

Event

UEG Week Berlin 2025

Topics

Nurses Pancreas Radiology & Imaging

Session

Hot topics in European gastroenterology

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Drug management in necrotising pancreatitis

Jacob Hamm 1

Affiliations

1 University Medical Center Goettingen, Goettingen, Germany

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Abstract

Event

UEG Week Berlin 2025

Topics

Endoscopy Pancreas

Session

Therapy update: Acute severe pancreatitis – It's all about timing!

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Andrea Anderloni 1

Affiliations

1 San Matteo Hospital, Pavia, Italy

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Abstract

Event

UEG Week Berlin 2025

Topics

Endoscopy Hepatobiliary

Session

Crash course: Tough endoscopists for tough stones

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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IMPACT OF FIRST AND FURTHER DECOMPENSATION IN METABOLIC-DYSFUNCTION ASSOCIATED COMPENSATED ADVANCED CHRONIC LIVER DISEASE

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

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IMPACT OF FIRST AND FURTHER DECOMPENSATION IN METABOLIC-DYSFUNCTION ASSOCIATED COMPENSATED ADVANCED CHRONIC LIVER DISEASE

Grazia Pennisi 1, Gabriele Di Maria 2, Vincent Wai Sun Wong 3, Victor De Ledinghen 4, Giada Sebastiani 5, Mauro Vigano 6, Anna Francanzani 7, Luca Miele 8, Elisabetta Bugianesi 9, Mattias Ekstedt 10, Roberta D'Ambrosio 11, Federico Ravaioli 12, Filippo Schepis 13, Fabio Marra 14, Alessio Aghemo 15, Gianluca Svegliati Baroni 16, Marcello Persico 17, Luca Valenti 6, Annalisa Berzigotti 18, Jacob George 19, Angelo Armandi 20, Patrik Nasr 10, Stergios Kechagias 10, Antonio Liguori 21, Dario Saltini 13, YULY PAULIN MENDOZA JAIMES 22, Vincenza Calvaruso 2, Marco Enea 2, Huapeng Lin 23, Giuseppe Infantino 2, Mario Masarone 17, Nicola Pugliese 24, Adele Tulone 2, Vito Di Marco 2, Calogero Camma 25, Salvatore Petta 26

Affiliations

1 Policlinico Paolo Giaccone, Palermo, Italy

2 University of Palermo, Palermo, Italy

3 University of Hong Kong, Hong Kong, China

4 Bordeaux University Hospital, Pessac, France

5 McGill University Health Centre, Montreal, Canada

6 University of Milan, Milan, Italy

7 Università degli Studi di Milano, Fondazione Ospedale Policlinico Ca Granda IRCCS, Milan, Italy

8 Fondazione Policlinico Gemelli IRCCS, Università Cattolica S. Cuore, Rome, Italy

9 AOU Città della Salute e della Scienza University of Torino, Torino, Italy, Torino, Italy

10 Linköping University, Linköping, Sweden

11 Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy

12 University of Bologna, Bologna, Italy

13 University of Modena, Modena, Italy

14 University of Florence, Florence, Italy

15 Humanitas University, Pieve Emanuele, Italy

16 Università Politecnica delle Marche, Ancona, Italy

17 University of Salerno, Salerno, Italy

18 Inselspital, University Hospital of Berne, Berne, Switzerland

19 University of Sydney, Sidney, Italy

20 University of Turin, Torino, Italy

21 Catholic University Of Sacred Heart, Rome, Rome, Italy

22 Inselspital, DBMR, university of Berm, Bern, Switzerland

23 The Chinese University of Hong Kong, Hong Kong, Italy

24 Istituto Clinico Humanitas IRCCS, Rozzano, Italy

25 UOC Gastroenterologia Ed Epatologia, Palermo, Italy

26 University of Palermo Italy 48.37, Palermo, Italy

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Abstract

Introduction

The first and further decompensation mark the natural history and the risk of mortality in patients with cirrhosis. We assessed the cumulative incidence of first and further (acute and non-acute) decompensation and evaluated their impact on liver-related death (LR-D) in patients with compensated advanced chronic liver disease (cACLD) due to metabolic dysfunction-associated steatotic liver disease (MASLD).

Aims & Methods

International multicenter retrospective study (17 centers) on 6,061 consecutive patients with clinical (LSM>10 kPa) or biopsy-proven (F3-F4 fibrosis) diagnosis of cACLD due to MASLD. First and further decompensation were defined according to Baveno VII criteria. Competing risk analysis by cumulative incidence functions and Cause-specific Cox models with baseline and time-dependent variables were performed. A multistate model was built to better assess the clinical course of cACLD due to MASLD.

Results

The cumulative incidence of the first decompensation was 3.5% (95% C.I 3.0-4.1) at 5 years, increasing 19-fold the risk of LR-D using Cox analysis; the cumulative incidence of further decompensation was 43.9% (95% C.I 37.2-50.2) at 5 years among patients with first decompensation, additionally increasing 1.5-times the risk of LR-D. Ascites, followed by variceal bleeding, were the most common events in both first and further decompensation. Hepatocellular carcinoma (HCC) further independently increased the risk of LR-D by 3- and 1.4-fold in the whole cohort of cACLD due to MASLD and in those who experienced first decompensation, respectively.

Conclusion

The first and further decompensations represent tipping points in the clinical course of patients with cACLD due to MASLD, increasing 19-times and additionally 1.5-times the risk of LR-D. HCC is an independent predictor of LR-D in patients with cACLD due to MASLD, resulting in an additional risk of LR-D when associated with both first and further decompensation.

Event

UEG Week Berlin 2025

Topics

Hepatobiliary IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Predicting and understanding early stages of advanced liver disease

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Najib Ben Khaled

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Difficult stones: Is it the stone or the endoscopist?

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Salvatore Petta

Diverticulitis: When not to be worried?

Johannes Kurt Schultz

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

Diverticulitis: When not to be worried?

Johannes Kurt Schultz 1

Affiliations

1 Univertsity of Oslo, Oslo, Norway

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Abstract

Event

UEG Week Berlin 2025

Topics

Colorectal Hepatobiliary Pancreas

Session

Predicting disease severity

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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