Feasibility of Comprehensive Genomic Profiling for Biliary Tract Cancer Using Transpapillary Biopsy Samples: A Prospective Study.

IF 2.8 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Hepato‐Biliary‐Pancreatic Sciences Pub Date : 2026-05-06 DOI:10.1002/jhbp.70123

Kazuya Miyamoto, Kazuyuki Matsumoto, Toshiaki Ohara, Masayoshi Fujisawa, Hirohumi Inoue, Ryosuke Sato, Akihiro Matsumi, Yuki Fujii, Daisuke Uchida, Motoyuki Otsuka

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引用次数: 0

Abstract

Background: Patients with biliary tract cancer (BTC) often have actionable mutations, and comprehensive genomic profiling (CGP) plays an important role. However, the feasibility of CGP using transpapillary biopsy (TPB) samples remains unclear.

Methods: Thirty patients with suspected BTC based on radiographic imaging were enrolled. Pre-analytical criteria for CGP suitability were based on the OncoGuide NCC Oncopanel System (NCCOP) and FoundationOne CDx (F1CDx). Each patient underwent six biopsies using an endoscopic introducer: five biopsy samples were preserved as formalin-fixed paraffin-embedded (FFPE) samples and one as a fresh frozen (FF) sample. DNA quality indicators were compared between the two groups.

Results: Malignancy was confirmed in 29 patients, and one had a benign biliary stricture. Suitability rate was 31% (9/29) for NCCOP and 3.4% (1/29) for F1CDx. Compared to FFPE samples, FF samples demonstrated significantly higher DNA concentration [ng/μL, interquartile range (IQR)], [0.34 (0.16-0.95) vs. 37.8 (11.6-67.6), p < 0.001] and DNA integrity number (IQR) [7.1 (6.8-7.3) vs. 8.9 (8.3-9), p = 0.021].

Conclusions: Introducer-assisted multipass TPB may increase the rate of obtaining adequate CGP specimens, but its suitability remains limited and strongly panel dependent. Since FF samples have better DNA quality, establishing a system detailing their use is desirable.

Trial registration: ClinicalTrials.gov identifier: UMIN 000049826.

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利用经乳头活检样本对胆道癌进行全面基因组分析的可行性：一项前瞻性研究。

背景：胆道癌（BTC）患者通常存在可操作的突变，综合基因组谱分析（CGP）在其中起着重要作用。然而，使用经乳头活检（TPB）样本进行CGP的可行性尚不清楚。方法：选取30例经影像学检查疑似BTC的患者。CGP适用性的分析前标准基于OncoGuide NCC oncoppanel System （NCCOP）和FoundationOne CDx （F1CDx）。每位患者使用内镜引入器进行了6次活检：5个活检样本作为福尔马林固定石蜡包埋（FFPE）样本保存，1个作为新鲜冷冻（FF）样本保存。比较两组的DNA质量指标。结果：29例确诊为恶性，1例为良性胆道狭窄。NCCOP的适宜率为31% (9/29)，F1CDx的适宜率为3.4%（1/29）。与FFPE样品相比，FF样品显示出更高的DNA浓度[ng/μL，四分位间距（IQR）], [0.34 (0.16-0.95) vs. 37.8 (11.6-67.6)]， p结论：引入器辅助的多通TPB可能增加获得足够CGP样品的率，但其适用性仍然有限且强烈依赖于群体。由于FF样品具有更好的DNA质量，建立一个详细说明其使用的系统是可取的。试验注册：ClinicalTrials.gov标识符：UMIN 000049826。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Hepato‐Biliary‐Pancreatic Sciences GASTROENTEROLOGY & HEPATOLOGY-SURGERY

自引率

10.00%

发文量

178

审稿时长

6-12 weeks

期刊介绍： The Journal of Hepato-Biliary-Pancreatic Sciences (JHBPS) is the leading peer-reviewed journal in the field of hepato-biliary-pancreatic sciences. JHBPS publishes articles dealing with clinical research as well as translational research on all aspects of this field. Coverage includes Original Article, Review Article, Images of Interest, Rapid Communication and an announcement section. Letters to the Editor and comments on the journal’s policies or content are also included. JHBPS welcomes submissions from surgeons, physicians, endoscopists, radiologists, oncologists, and pathologists.