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

NCT ID: NCT07023562

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2027-05-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABC group

Group Type EXPERIMENTAL

ABC suction sequence

Intervention Type PROCEDURE

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

ACB group

Group Type EXPERIMENTAL

ACB suction sequence

Intervention Type PROCEDURE

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

BAC group

Group Type EXPERIMENTAL

BAC suction sequence

Intervention Type PROCEDURE

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

BCA group

Group Type EXPERIMENTAL

BCA suction sequence

Intervention Type PROCEDURE

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

CAB group

Group Type EXPERIMENTAL

CAB suction sequence

Intervention Type PROCEDURE

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

CBA group

Group Type EXPERIMENTAL

CBA suction sequence

Intervention Type PROCEDURE

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

Interventions

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ABC suction sequence

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

Intervention Type PROCEDURE

ACB suction sequence

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

Intervention Type PROCEDURE

BAC suction sequence

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

Intervention Type PROCEDURE

BCA suction sequence

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

Intervention Type PROCEDURE

CAB suction sequence

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

Intervention Type PROCEDURE

CBA suction sequence

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Department of Gastroenterology, Changhai Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhao Shen Li, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Jia Yi Ma, M.D

Role: CONTACT

+8613621819595

Kai Xuan Wang, M.D

Role: CONTACT

Facility Contacts

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Jia Yi Ma, M.D

Role: primary

+8613621819595

Other Identifiers

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KTSB20250423035

Identifier Type: -

Identifier Source: org_study_id

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