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Effect of on-site cytopathological evaluation (ROSE) on the accuracy of pancreatic solid occupancy by EUS-FNA by trained endoscopic physician

Effect of on-site cytopathological evaluation (ROSE) on the accuracy of pancreatic solid occupancy by EUS-FNA by trained endoscopic physician

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017047
Enrollment
Unknown
Registered
2018-07-10
Start date
2018-07-30
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

pancreatic solid occupancy

Interventions

trained&#32
Index test:On-site&#32
evaluation&#32
(ROSE)&#32
of&#32
EUS-FNA&#32
by&#32

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; 2. Ultrasound/CT/MRI suggests that the pancreas contains a solid mass and requires EUS-FNA to define the nature of the lesion. EUS confirms that the long axis diameter of the lesion is >1 cm. In the EUS image, the lesions are mainly solid components (solid/cystic echo>60%, in solid space, some lesions may have cystic echo in ultrasound images due to necrotic liquefaction); 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The patient has abnormal blood coagulation (platelet count 1.5); 2. Recent oral anticoagulant drugs; 3. There is a blood vessel in the puncture path, or the puncture distance is too far, and there is a history of digestive tract diversion surgery, and it is expected that the EUS-FNA operation cannot be completed; 4. Can not tolerate anesthesia; 5. Disagree to participate in the study; 6.The researcher judges the non-cooperator.

Design outcomes

Primary

MeasureTime frame
diagnostic efficacy (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of the pancreatic solid malignant tumors;

Secondary

MeasureTime frame
satisfaction with cytological acquisition of solid occupancy;number of punctures;time of operation;incidence of complications;

Countries

China

Contacts

Public ContactYing Lv

Nanjing Drum Tower Hospital

13770755008@126.com+86 13770755008

Outcome results

None listed

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