Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07023549

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pancreatic Diseases Digestive System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABC

Procedure

Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.

ACB

Procedure

Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.

BAC

Procedure

Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.

BCA

Procedure

Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.

CAB

Procedure

Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.

CBA

Procedure

Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.

Primary outcomes

  1. Tissue adequacy

    Time frame: 2 months

    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.

Secondary outcomes

  1. Cellularity

    Time frame: 2 months

    Grade A: Satisfactory, with more than 4 clusters, each containing at least 10 cells for cytological analysis; Grade B: Adequate, with 2-4 clusters, each containing at least 10 cells for cytological analysis; Grade C: Insufficient, with<2 clusters suitable for cytological analysis or non-representative samples, or<50 cells with clear nuclear structures.

  2. Blood contamination

    Time frame: 2 months

    The histological blood contamination score is assessed by grading the percentage of red blood cells in the entire 40x magnified field of view. Grade A: Red blood cells are present in<25%of the slides; Grade B: Red blood cells occupy 25%-50%of the slide; Grade C: Red blood cells are present in>50%of the slides; Grade D: No tissue.

  3. Diagnostic accuracy

    Time frame: 6 months

    Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.

  4. Diagnostic sensitivity

    Time frame: 6 months

    Diagnostic sensitivity was calculated as the proportion of true positives in patient cases.

  5. Diagnostic specificity

    Time frame: 6 months

    Diagnostic specificity was calculated as proportion of true negative in healthy cases.

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Yi Ma, M.D

CONTACT

[email protected]

+8613621819595

Kai Xuan Wang, M.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.