Clinical trial NCT07007832: Bile Omics for Diagnosing Indeterminate Biliary Strictures
Official title: The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholangiocarcinoma
Gallbladder Cancer and Extrahepatic Cholangiocarcinoma
Pancreatic Cancer
Bile Duct Strictures of Unknown Origin
Bile Duct Strictures
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Naval Medical University
name: Shanghai 6th People's Hospital
First posted: 2025-06-06
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in top-tier academic medical center in Shanghai, China (Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; The Third Affiliated Hospital of Naval Medical University; Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine)

Brief summary: The diagnosis of malignant biliary strictures remains a challenging aspect of biliary endoscopy. Molecular biological testing techniques based on bile have been reported to improve detection rates. However, whether the combination of bile-based omics studies and biliary brush cytology/biopsy can enhance diagnostic sensitivity has not yet been reported. This study aims to collect bile from patients with malignant biliary strictures, screen for molecular markers associated with biliary malignancies through multi-omics analysis, and subsequently validate these markers to establish a bile-based molecular diagnostic model.


Eligibility criteria: Inclusion Criteria:

* Indeterminate biliary strictures
* Aged 18-90 years
* Underwent ERCP with biliary biopsy and/or brush cytology

Exclusion Criteria:

* Coagulation disorders
* Pregnancy
* Malignancies of other organs unrelated to biliary strictures
* Declined participation

Primary outcomes:
measure: Diagnostic sensitivity
timeFrame: histologically or cytogically confirmed , or followed up for 6 months
Secondary outcomes:
measure: accuracy
timeFrame: histologically or cytologically confirmed or followed up for 6 months
measure: Specificity
timeFrame: histologically or cytologically confirmed or followed up for 6 months
measure: Positive predictive value,
timeFrame: histologically or cytologically confirmed or followed up for 6 months
measure: negative predictive value
timeFrame: histologically or cytologically confirmed or followed up for 6 months
measure: AUC area (histologically or cytologically confirmed or followed up for 6 months)
timeFrame: up for 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xueying Ding, MD
role: STUDY_CHAIR
References:
citation: Bhawal R, Oberg AL, Zhang S, Kohli M. Challenges and Opportunities in Clinical Applications of Blood-Based Proteomics in Cancer. Cancers (Basel). 2020 Aug 27;12(9):2428. doi: 10.3390/cancers12092428.
citation: Arechederra M, Rullan M, Amat I, Oyon D, Zabalza L, Elizalde M, Latasa MU, Mercado MR, Ruiz-Clavijo D, Saldana C, Fernandez-Urien I, Carrascosa J, Jusue V, Guerrero-Setas D, Zazpe C, Gonzalez-Borja I, Sangro B, Herranz JM, Purroy A, Gil I, Nelson LJ, Vila JJ, Krawczyk M, Zieniewicz K, Patkowski W, Milkiewicz P, Cubero FJ, Alkorta-Aranburu G, G Fernandez-Barrena M, Urman JM, Berasain C, Avila MA. Next-generation sequencing of bile cell-free DNA for the early detection of patients with malignant biliary strictures. Gut. 2022 Jun;71(6):1141-1151. doi: 10.1136/gutjnl-2021-325178. Epub 2021 Jul 20.
citation: Singhi AD, Nikiforova MN, Chennat J, Papachristou GI, Khalid A, Rabinovitz M, Das R, Sarkaria S, Ayasso MS, Wald AI, Monaco SE, Nalesnik M, Ohori NP, Geller D, Tsung A, Zureikat AH, Zeh H, Marsh JW, Hogg M, Lee K, Bartlett DL, Pingpank JF, Humar A, Bahary N, Dasyam AK, Brand R, Fasanella KE, McGrath K, Slivka A. Integrating next-generation sequencing to endoscopic retrograde cholangiopancreatography (ERCP)-obtained biliary specimens improves the detection and management of patients with malignant bile duct strictures. Gut. 2020 Jan;69(1):52-61. doi: 10.1136/gutjnl-2018-317817. Epub 2019 Apr 10.
citation: de Oliveira PVAG, de Moura DTH, Ribeiro IB, Bazarbashi AN, Franzini TAP, Dos Santos MEL, Bernardo WM, de Moura EGH. Efficacy of digital single-operator cholangioscopy in the visual interpretation of indeterminate biliary strictures: a systematic review and meta-analysis. Surg Endosc. 2020 Aug;34(8):3321-3329. doi: 10.1007/s00464-020-07583-8. Epub 2020 Apr 27.
citation: Platt KD, Schulman AR. Increasing the Yield: When More Is Better. Am J Gastroenterol. 2022 May 1;117(5):729-730. doi: 10.14309/ajg.0000000000001724. Epub 2022 Mar 14.
citation: Wang J, Xia M, Jin Y, Zheng H, Shen Z, Dai W, Li X, Kang M, Wan R, Lu L, Hu B, Wan X, Cai X. More Endoscopy-Based Brushing Passes Improve the Detection of Malignant Biliary Strictures: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2022 May 1;117(5):733-739. doi: 10.14309/ajg.0000000000001666. Epub 2022 Feb 2.
citation: Korc P, Sherman S. ERCP tissue sampling. Gastrointest Endosc. 2016 Oct;84(4):557-71. doi: 10.1016/j.gie.2016.04.039. Epub 2016 May 6. No abstract available.
citation: Elmunzer BJ, Maranki JL, Gomez V, Tavakkoli A, Sauer BG, Limketkai BN, Brennan EA, Attridge EM, Brigham TJ, Wang AY. ACG Clinical Guideline: Diagnosis and Management of Biliary Strictures. Am J Gastroenterol. 2023 Mar 1;118(3):405-426. doi: 10.14309/ajg.0000000000002190. Epub 2023 Jan 17.
citation: Fujii-Lau LL, Thosani NC, Al-Haddad M, Acoba J, Wray CJ, Zvavanjanja R, Amateau SK, Buxbaum JL, Wani S, Calderwood AH, Chalhoub JM, Coelho-Prabhu N, Desai M, Elhanafi SE, Fishman DS, Forbes N, Jamil LH, Jue TL, Kohli DR, Kwon RS, Law JK, Lee JK, Machicado JD, Marya NB, Pawa S, Ruan W, Sawhney MS, Sheth SG, Storm A, Thiruvengadam NR, Qumseya BJ; (ASGE Standards of Practice Committee Chair [2020-2023]). American Society for Gastrointestinal Endoscopy guideline on role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: methodology and review of evidence. Gastrointest Endosc. 2023 Nov;98(5):694-712.e8. doi: 10.1016/j.gie.2023.06.007. Epub 2023 Jun 10.