The 22G Trident Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy

Naval Military Medical University

Status: Not yet enrolling

Conditions: Pancreatic Diseases

Treatments: Procedure: CBA suction sequence; Procedure: ABC suction sequence; Procedure: BAC suction sequence; Procedure: ACB suction sequence; Procedure: CAB suction sequence; Procedure: BCA suction sequence

Study type: Interventional

Funder types: Other

Identifiers

NCT07023562

KTSB20250423035

Details and patient eligibility

About

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.

Full 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 Trident 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 (EUS-FNB) using a 22G Trident needle.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)

  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

• (Before the trial, participants could not be enrolled if they met any of the following requirements)

  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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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270 participants in 6 patient groups

ABC group

Experimental group

Treatment:

Procedure: ABC suction sequence

ACB group

Experimental group

Treatment:

Procedure: ACB suction sequence

BAC group

Experimental group

Treatment:

Procedure: BAC suction sequence

BCA group

Experimental group

Treatment:

Procedure: BCA suction sequence

CAB group

Experimental group

Treatment:

Procedure: CAB suction sequence

CBA group

Experimental group

Treatment:

Procedure: CBA suction sequence