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Not yet recruiting NCT07023549

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

No phase Interventional Pancreatic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABC, ACB, BAC, BCA.
Who it may be relevant to
Registry conditions: Pancreatic Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Procedure ABC
    Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
  • Procedure ACB
    Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
  • Procedure BAC
    Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
  • Procedure BCA
    Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
  • Procedure CAB
    Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
  • Procedure CBA
    Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.

Primary outcome measures

  • Tissue adequacy [Time frame: 2 months]
Secondary outcome measures (5)
  • Cellularity [Time frame: 2 months]
  • Blood contamination [Time frame: 2 months]
  • Diagnostic accuracy [Time frame: 6 months]
  • Diagnostic sensitivity [Time frame: 6 months]
  • Diagnostic specificity [Time frame: 6 months]

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Changhai Hospital — Shanghai

Identifiers

NCT: NCT07023549 · KTSB20250423034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗