Status:
NOT_YET_RECRUITING
Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions
Lead Sponsor:
Changhai Hospital
Conditions:
Pancreatic Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures...
Eligibility Criteria
Inclusion
- (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
- 18-80 years old (inclusive), male and female;
- patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
- written informed consent was obtained;
Exclusion
- (Before the trial, participants could not be enrolled if they met any of the following requirements)
- contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
- bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
- confirmed pregnancy or possible pregnancy;
- pathological diagnosis has been obtained by other methods;
- refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.
- other situations where EUS-FNB could not be performed.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2026
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06994611
Start Date
June 25 2025
End Date
August 26 2026
Last Update
June 6 2025
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433