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

A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Suction Technique, Slow-pull Method and Wet Suction Technique on Specimen Quality and Diagnostic Accuracy in Endoscopic Ultrasound-guided Fine-needle Aspiration

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.

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Lymphoma; Inflammation; Cancer; Infection; Sarcoid; Mass Lesion
• Intervention / Treatment: Procedure: Standard suction, slow-pull, wet suction; Procedure: Standard suction, wet suction, slow-pull; Procedure: Slow-pull, standard suction, wet suction; Procedure: Slow-pull, wet suction, standard suction; Procedure: Wet suction, standard suction, slow-pull; Procedure: Wet suction, slow-pull, standard suction

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Ning Cui, M.D.
      • Sub-Investigator: Jiwang Cao, M.D.
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital, Shandong University
      • Contact: Limei Wang, M.D.
      • Sub-Investigator: Ning Zhong, M.D.
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Tianyin Chen, M.D.
      • Principal Investigator: Yiqun Zhang, M.D.
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
      • Contact: Sijie Hao, M.D.
      • Sub-Investigator: Chen Jin, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of standard suction technique	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.	1 year
Diagnostic yield of slow-pull technique	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.	1 year
Diagnostic yield of wet suction technique	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.	1 year
Specimen quality score of standard suction	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.	Immediate
Specimen quality score of slow-pull	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.	Immediate
Specimen quality score of wet suction	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.	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Including bleeding, infection, pneumonia, perforation and other procedure related adverse events.	1 week

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: EUS-FNA
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: B2017-195

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