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

Not Applicable

• Conditions: Neoplasms; Infection; Inflammation; Lymphoma; Cancer; Sarcoid; Mass Lesion
• Interventions: Procedure: Slow-pull, standard suction, wet suction; Procedure: Wet suction, standard suction, slow-pull; Procedure: Standard suction, slow-pull, wet suction; Procedure: Slow-pull, wet suction, standard suction; Procedure: Standard suction, wet suction, slow-pull; Procedure: Wet suction, slow-pull, standard suction

• Registration Number: NCT03674710
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-12-18
• Status Verified: 2018-09
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-14
• Last Update Submitted: 2018-09-14
• Study First Posted: 2018-09-17
• Last Update Posted: 2018-09-17
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Slow-pull, standard suction, wet suction	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 E	Wet suction, standard suction, slow-pull	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 A	Standard suction, slow-pull, wet suction	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 D	Slow-pull, wet suction, standard suction	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 B	Standard suction, wet suction, slow-pull	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 F	Wet suction, slow-pull, standard suction	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of standard suction technique	1 year	A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Specimen quality score of wet suction	Immediate	EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for \<10/HPF, 1 for \<50/HPF, 2 for \>50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Diagnostic yield of slow-pull technique	1 year	A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Specimen quality score of standard suction	Immediate	EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for \<10/High power field(HPF), 1 for \<50/HPF, 2 for \>50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Diagnostic yield of wet suction technique	1 year	A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Specimen quality score of slow-pull	Immediate	EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for \<10/HPF, 1 for \<50/HPF, 2 for \>50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.

Secondary Outcome Measures

Name	Time	Method
Adverse event	1 week	Including bleeding, infection, pneumonia, perforation and other procedure related adverse events.

Trial Locations

Locations (4)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China