The Comparison of Wet Suction and Dry Suction Technique in EUS-FNA for the Outcomes in Pancreatic Solid Lesions

NCT03821974 | Completed

• 1 other identifier: EUS2019-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized controlled trial is to evaluate whether wet suction technique (WST), compared with dry suction technique (DST), shall present a better outcome with regard to the diagnostic yield and specimen quality of patients with solid lesions in the pancreatics.

Conditions

Pancreatic Solid Lesions

Keywords

Pancreatic solid lesions; wet suction technique; dry suction technique

Outcome Measures

Primary Outcomes (1)

• The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.

  The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.

  20 weeks

Secondary Outcomes (4)

• The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.

  20 weeks

• The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.

  20 weeks

• The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.

  20 weeks

• The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.

  20 weeks

Study Arms (2)

dry group

EXPERIMENTAL

The sequence of the technique of the puncture is dry-wet-dry-wet.

Procedure: wet suction technique; Procedure: dry suction technique

wet group

EXPERIMENTAL

The sequence of the technique of the puncture is wet-dry-wet-dry.

Procedure: wet suction technique; Procedure: dry suction technique

Interventions

wet suction technique PROCEDURE

For the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.

dry group; wet group

dry suction technique PROCEDURE

For the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.

dry group; wet group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years, \< 80 years
• female or male
• Patients are required to undergo EUS-FNA after undergoing imaging examination (MRI, CT, or ultrasonography) which identify that the pancreatic lesions are existing and solid.
• Agree to attend this study and signed informed consent letter

You may not qualify if:

• bad physical condition, including hemoglobin ≤ 8.0 g/dl, severe cardiorespiratory dysfunction, and so on
• Coagulopathy (platelet count \< 50,000/mm3, international normalized ratio \> 1.5) or having taken oral anticoagulation agents such as aspirin or warfarin in the previous week
• Be rejected by anesthesia
• Acute pancreatitis in the previous 2 weeks
• Pregnant or lactation period
• Psychiatric disease, drug addiction, or other reason for unreliable follow-up or questionnaires
• Don't agree to attend this study and absence of informed consent

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The third Xiangya Hospital of central south University

Changsha, Hunan, 410003, China

Location

Study Officials

• Li Tian, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Ting Tong, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 30, 2019
• Study Start: January 3, 2019
• Primary Completion: September 30, 2019
• Study Completion: March 31, 2020
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)