The 22G Trident Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy
Comparing the Sample Quality of 22G Trident Needle Combined With Different Aspiration Techniques in EUS-Guided Fine-Needle Biopsy of Pancreatic Solid Lesions: A Randomized Controlled Multicenter Clinical Study
1 other identifier
interventional
270
1 country
1
Brief Summary
The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Trident needle combined with three different aspiration techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2025
CompletedFirst Posted
Study publicly available on registry
June 17, 2025
CompletedStudy Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 26, 2027
June 17, 2025
June 1, 2025
1.9 years
June 8, 2025
June 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue adequacy
Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample.
2 months
Secondary Outcomes (5)
Cellularity
2 months
Blood contamination
2 months
Diagnostic accuracy
6 months
Diagnostic sensitivity
6 months
Diagnostic specificity
6 months
Study Arms (6)
ABC group
EXPERIMENTALACB group
EXPERIMENTALBAC group
EXPERIMENTALBCA group
EXPERIMENTALCAB group
EXPERIMENTALCBA group
EXPERIMENTALInterventions
Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.
Eligibility Criteria
You may qualify if:
- (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
- 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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao Shen Li, M.D
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Gastroenterology, Changhai Hospital
Study Record Dates
First Submitted
June 8, 2025
First Posted
June 17, 2025
Study Start
June 25, 2025
Primary Completion (Estimated)
May 26, 2027
Study Completion (Estimated)
May 26, 2027
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share