Skip to main content
OpenTrials
Completed

NCT Number: NCT03821974

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Solid Lesions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The third Xiangya Hospital of central south University

Changsha, Hunan, 410003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 20 weeks

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

Secondary outcomes

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

    Time frame: 20 weeks

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

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

    Time frame: 20 weeks

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

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

    Time frame: 20 weeks

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.