Clinical trial NCT07023549: The 22G Franseen Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy
Official title: Comparing the Sample Quality of 22G Franseen Needle Combined With Different Aspiration Techniques in Endoscopic Ultrasound-Guided Fine-Needle Biopsy of Pancreatic Solid Lesions: A Randomized Controlled Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Diseases
Keywords: 22G Franseen needle
solid pancreatic lesion
aspiration technique
Endoscopic ultrasound-guided fine-needle biopsy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.

Detailed description: Patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. Samples were collected using a 22G Franseen needle in different suction sequences. The advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for Endoscopic ultrasound-guided fine-needle biopsy using a 22G Franseen needle.

Eligibility criteria: Inclusion Criteria:

（1）18-80 years old (inclusive), male and female; （2）patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.

（3）written informed consent was obtained.

Exclusion Criteria:

1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
3. confirmed pregnancy or possible pregnancy;
4. pathological diagnosis has been obtained by other methods;
5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days;
6. other situations where EUS-FNB could not be performed.

Primary outcomes:
measure: Tissue adequacy
timeFrame: 2 months
Secondary outcomes:
measure: Cellularity
timeFrame: 2 months
measure: Blood contamination
timeFrame: 2 months
measure: Diagnostic accuracy
timeFrame: 6 months
measure: Diagnostic sensitivity
timeFrame: 6 months
measure: Diagnostic specificity
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China
name: Zhao Shen Li, M.D
role: PRINCIPAL_INVESTIGATOR
References: