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Effect of an artificial intelligence based Rapid On-Site Cytopathological Evaluationon (Rose) system for EUS-FNA on the accuracy of diagnosis of pancreatic solid lesions: a multicenter randomized controlled study

Effect of an artificial intelligence based Rapid On-Site Cytopathological Evaluationon (Rose) system for EUS-FNA on the accuracy of diagnosis of pancreatic solid lesions: a multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066112
Enrollment
Unknown
Registered
2022-11-24
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Pancreatic cancer

Interventions

AI-ROSE group:Artificial intelligence based Rapid On-Site Cytopathological Evaluationon
Human-ROSE group:Human Based Rapid On-Site Cytopathological Evaluationon

Sponsors

The Affiliated Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Ultrasound/CT/MRI suggestive of solid pancreatic occupancy requiring EUS-FNA to clarify the nature; EUS clearly confirmed and lesions >1 cm in diameter in the long axis and lesions with a predominantly solid component in EUS images (solid echogenicity/cystic echogenicity >60%, i.e. in solid occupancy, some lesions may have cystic echogenicity in ultrasound images due to the presence of necrotic liquefaction); 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patient has abnormal coagulation (platelet count 1.5); 2. Recent oral anticoagulant medication; 3. The presence of vessels in the puncture route or the presence of a puncture that is too far away or a history of GI diversion surgery that is not expected to complete the EUS-FNA operation; 4. Inability to tolerate anesthesia.

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;Positive predictive value;Negative predictive value;

Secondary

MeasureTime frame
Sample satisfaction;Puncture times;Operation time;

Countries

China

Contacts

Public ContactLyu Ying

The Affiliated Drum Tower Hospital of Nanjing University Medical School

13770755008@126.com+86 13770755008

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026