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Endoscopic ultrasonography-guided puncture of solid pancreatic masses with rapid staining of cell smears followed by whole slide imaging and artificial intelligence diagnosis: A prospective, multicenter study.

Endoscopic ultrasonography-guided puncture of solid pancreatic masses with rapid staining of cell smears followed by whole slide imaging and artificial intelligence diagnosis: A prospective, multicenter study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600134022
Enrollment
Unknown
Registered
2026-10-10
Start date
2025-04-16
Completion date
Unknown
Last updated
2026-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid pancratic lesion (such as pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, and non-tumor pancreatic benign lesions)

Interventions

Index test:Primary outcome: The accuracy of artificial intelligence based on deep learning. Secondary outcomes: These include the sensitivity, specificity, positive predictive value, negative predicti

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.A dated and signed informed consent form; 2.A commitment to abide by the research procedures and cooperate throughout the entire study; 3.Subjects aged 18 and above, regardless of gender; 4.Diagnosis or suspicion of a solid pancreatic space-occupying lesion based on imaging studies (B-mode ultrasound, CT, or MRI);

Exclusion criteria

Exclusion criteria: 1.Unable or refusing to sign the informed consent form; 2.Unable to suspend anticoagulation/antiplatelet therapy; 3.Pregnant or lactating; 4.Having a mental illness or other medical conditions that are unsuitable for undergoing FNA/B biopsy; 5.Presence of coagulation disorders (PLT 1.5); 6.Pancreatic cystic lesions; 7.Non-diagnostic EUS-FNA/B specimens; 8.Having less than 8 microscopic fields of interest (ROI) in the digital pathology images of the entire Diff-Quik smear slide;

Design outcomes

Primary

MeasureTime frame
Accuracy;—

Secondary

MeasureTime frame
Precision;PPV;Recall;NPV;Sensitivity;Specificity;—

Countries

China

Contacts

Public ContactDuowu Zou

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

zdw_pi@126.com+86 21 64370045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Oct 17, 2026