Recruiting NCT07007832
Bile Omics for Diagnosing Indeterminate Biliary Strictures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic retrograde cholangiopancreatography.
- Who it may be relevant to
- Registry conditions: Cholangiocarcinoma, Gallbladder Cancer and Extrahepatic Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Strictures of Unknown Origin. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures
Overview
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.
Interventions
- Procedure Endoscopic retrograde cholangiopancreatography
Since patients with biliary strictures almost universally require endoscopic biliary interventions for both diagnostic and drainage purposes, bile aspiration can be readily obtained during these procedures, facilitating subsequent analyses. However, proteomic and metabolomic profiling of bile in malignant biliary strictures remains unreported to date. This study aims to evaluate the diagnostic value of combining bile proteomics/metabolomics with biliary brush cytology/biopsy for malignant biliar
Primary outcome measures
- Diagnostic sensitivity [Time frame: histologically or cytogically confirmed , or followed up for 6 months]
Secondary outcome measures (5)
- accuracy [Time frame: histologically or cytologically confirmed or followed up for 6 months]
- Specificity [Time frame: histologically or cytologically confirmed or followed up for 6 months]
- Positive predictive value, [Time frame: histologically or cytologically confirmed or followed up for 6 months]
- negative predictive value [Time frame: histologically or cytologically confirmed or followed up for 6 months]
- AUC area (histologically or cytologically confirmed or followed up for 6 months) [Time frame: up for 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Publications
- 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. PMID 32867043
- 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. N PMID 34285068
- 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 cholangiopancreatograp PMID 30971436
- 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. PMID 32342216
- 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. PMID 35287142
- 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. PMID 35108222
- 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. PMID 27156656
- 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. PMID 36863037
Identifiers
NCT: NCT07007832 · [2025] No. 236