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Macroscopic on-site evaluation of endoscopic ultrasound-guided fine needle biopsy using a stereomicroscope: a prospective, randomized controlled trial

Macroscopic on-site evaluation of endoscopic ultrasound-guided fine needle biopsy using a stereomicroscope: a prospective, randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088047
Enrollment
Unknown
Registered
2024-08-09
Start date
2023-06-21
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

pancreatic disease

Interventions

stereomicroscopic MOSE:When performing EUS-FNB for pancreatic solid masses, after each biopsy pass, insert the needle core, push the sample into a 3cm culture dish with a small amount of liquid based
conventional empirical evaluation:When performing EUS-FNB for pancreatic solid masses, the number of puncture passes is determined by the endoscopist.

Sponsors

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Signed and dated informed consent form 2. Promise to comply with research procedures and cooperate in implementing full process research 3. Subjects aged 18 and above, regardless of gender 4. Imaging examination (ultrasound, CT or MRI) to diagnose or suspect solid pancreatic mass 5. Lesions larger than 1cm

Exclusion criteria

Exclusion criteria: 1. Inability or refusal to sign informed consent form 2. Inability to pause anticoagulant/antiplatelet therapy 3. Being pregnant or breastfeeding 4. Cystic pancreatic lesions 5. Existence of coagulation disorders (PLT1.5) 6. History of mental illness 7. Other medical situations that are not suitable for receiving FNB puncture

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy;

Secondary

MeasureTime frame
Diagnostic adequacy;Puncture passes;Operation time;

Countries

China

Contacts

Public ContactZou Duowu

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

zdw_pi@163.com+86 139 0161 7608

Outcome results

None listed

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