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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Diseases
• Intervention / Treatment: Procedure: ABC suction sequence; Procedure: ACB suction sequence; Procedure: BAC suction sequence; Procedure: BCA suction sequence; Procedure: CAB suction sequence; Procedure: CBA suction sequence

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia Yi Ma, M.D; Phone Number: +8613621819595; Email: 504043536@qq.com
• Study Contact Backup: Name: Kai Xuan Wang, M.D; Email: wangkaixuan224007@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital
      • Contact: Jia Yi Ma, M.D; Phone Number: +8613621819595; Email: 504043536@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABC group	Procedure: ABC suction sequence; Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
Experimental: ACB group	Procedure: ACB suction sequence; Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
Experimental: BAC group	Procedure: BAC suction sequence; Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
Experimental: BCA group	Procedure: BCA suction sequence; Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
Experimental: CAB group	Procedure: CAB suction sequence; Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
Experimental: CBA group	Procedure: CBA suction sequence; Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.	6 months
Cellularity	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 months
Blood contamination	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.	2 months
Diagnostic sensitivity	Diagnostic sensitivity was calculated as the proportion of true positives in patient cases.	6 months
Diagnostic specificity	Diagnostic specificity was calculated as proportion of true negative in healthy cases.	6 months

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Zhao Shen Li, M.D, Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2025
• Primary Completion (Estimated): May 26, 2027
• Study Completion (Estimated): May 26, 2027

Study Registration Dates

• First Submitted: June 8, 2025
• First Submitted That Met QC Criteria: June 15, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 15, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: EUS-FNB; solid pancreatic lesion; sample processing
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: KTSB20250423035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No