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

Fudan University

Status: Unknown

Conditions: Inflammation; Infection; Sarcoid; Neoplasms; Lymphoma; Cancer; Mass Lesion

Treatments: Procedure: Standard suction, slow-pull, wet suction; Procedure: Wet suction, slow-pull, standard suction; Procedure: Slow-pull, wet suction, standard suction; Procedure: Slow-pull, standard suction, wet suction; Procedure: Standard suction, wet suction, slow-pull; Procedure: Wet suction, standard suction, slow-pull

Study type: Interventional

Funder types: Other

Identifiers

NCT03674710

B2017-195

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 6 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Procedure: Standard suction, slow-pull, wet suction

Group B

Experimental group

Description:

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.

Treatment:

Procedure: Standard suction, wet suction, slow-pull

Group C

Experimental group

Description:

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.

Treatment:

Procedure: Slow-pull, standard suction, wet suction

Group D

Experimental group

Description:

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.

Treatment:

Procedure: Slow-pull, wet suction, standard suction

Group E

Experimental group

Description:

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.

Treatment:

Procedure: Wet suction, standard suction, slow-pull

Group F

Experimental group

Description:

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.

Treatment:

Procedure: Wet suction, slow-pull, standard suction