A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Diagnostic Value of Different EUS-FNA Techniques

NCT ID: NCT03674710

Last Updated: 2018-09-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (EUS-FNA) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. Investigators intend to compare the effectiveness and safety of the three methods in order to discover the optimized technique for obtaining diagnostic material and making accurate diagnosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms Infection Inflammation Lymphoma Cancer Sarcoid Mass Lesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Patients assigned to group A will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group Type EXPERIMENTAL

Standard suction, slow-pull, wet suction

Intervention Type PROCEDURE

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group B

Patients assigned to group B will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group Type EXPERIMENTAL

Standard suction, wet suction, slow-pull

Intervention Type PROCEDURE

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group C

Patients assigned to group C will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group Type EXPERIMENTAL

Slow-pull, standard suction, wet suction

Intervention Type PROCEDURE

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group D

Patients assigned to group D will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group Type EXPERIMENTAL

Slow-pull, wet suction, standard suction

Intervention Type PROCEDURE

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group E

Patients assigned to group E will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group Type EXPERIMENTAL

Wet suction, standard suction, slow-pull

Intervention Type PROCEDURE

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group F

Patients assigned to group F will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Group Type EXPERIMENTAL

Wet suction, slow-pull, standard suction

Intervention Type PROCEDURE

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard suction, slow-pull, wet suction

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Intervention Type PROCEDURE

Standard suction, wet suction, slow-pull

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Intervention Type PROCEDURE

Slow-pull, standard suction, wet suction

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Intervention Type PROCEDURE

Slow-pull, wet suction, standard suction

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Intervention Type PROCEDURE

Wet suction, standard suction, slow-pull

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Intervention Type PROCEDURE

Wet suction, slow-pull, standard suction

Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* In-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for EUS-FNA.

Exclusion Criteria

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Cystic lesions
* Inaccessible lesions to EUS
* Contraindications for conscious sedation
* Uncooperative patients
* Refusal to consent form
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tianyin Chen, M.D.

Role: CONTACT

+8613801635303

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ning Cui, M.D.

Role: primary

Limei Wang, M.D.

Role: primary

Tianyin Chen, M.D.

Role: primary

Sijie Hao, M.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2017-195

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diagnostic Efficacy Of 3 EUS-FNB Techniques
NCT05825729 RECRUITING PHASE4
EUS-FNA With and Without Suction
NCT02072915 COMPLETED NA