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

Sponsor

The Third Xiangya Hospital of Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT03821974

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Solid Lesions	Procedure: wet suction technique Procedure: dry suction technique	N/A

Detailed Description

Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has become an inevitable indispensable method for acquiring a pathological diagnosis in a variety of clinical conditions. It has been widely used due to the high sensitivity, specificity and safety. In order to improve the puncture efficiency of FNA, many domestic and oversea scholars have conducted several clinical trials. Among them, there are many studies on the type of needle, needle pattern, slow pull or vacuum suction, and there are only two related reports on wet suction (saline) and dry suction technique. There still have many controversies in the researchers about which technique is more dominant in the wet or dry suction. The wet suction technique is relying on pre-flushing the needle with saline to replace the column of air with fluid followed by aspiration at the proximal end, using a prefilled suction syringe with saline. It has been suggested that the presence of a saline-solution column might keep the needle from getting clogged while avoiding the inherent inconvenience of a metal stylet, so that it can improve the quality of specimens, diminish the contamination of blood, and increase the diagnostic yield and accuracy. Wet suction may become the development trend of EUS-FNA in the future because the application of wet suction is expected to improve the diagnostic efficiency and the quality of samples in FNA.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

The Comparison of Wet Suction Technique and Dry Suction Technique in Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) for the Outcomes in Pancreatic Solid Lesions: a Prospective, Randomized Controlled, Blinded Trial

Actual Study Start Date :

Jan 3, 2019

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dry group The sequence of the technique of the puncture is dry-wet-dry-wet.	Procedure: wet suction technique 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. Procedure: dry suction technique 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.
Experimental: wet group The sequence of the technique of the puncture is wet-dry-wet-dry.	Procedure: wet suction technique 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. Procedure: dry suction technique 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.

Arm

Intervention/Treatment

Experimental: dry group

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

Procedure: wet suction technique

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.

Procedure: dry suction technique

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.

Experimental: wet group

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

Procedure: wet suction technique

Procedure: dry suction technique

Outcome Measures

Primary Outcome Measures

The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique. [20 weeks]
The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.

Secondary Outcome Measures

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 second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.
The third outcome is the diagnose yield in benign 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.
The forth outcome is the diagnose yield in malignant 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.
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]
The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The third Xiangya Hospital of central south University	Changsha	Hunan	China	410003

Sponsors and Collaborators

The Third Xiangya Hospital of Central South University

Investigators

Principal Investigator: Li Tian, MD, The Third Xiangya Hospital of Central South University
Principal Investigator: Ting Tong, MD, The Third Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Third Xiangya Hospital of Central South University

ClinicalTrials.gov Identifier:

NCT03821974

Other Study ID Numbers:

EUS2019-001

First Posted:

Jan 30, 2019

Last Update Posted:

Jun 16, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Third Xiangya Hospital of Central South University

Pancreatic solid lesions

wet suction technique

dry suction technique

Study Results

No Results Posted as of Jun 16, 2021