Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid

Status Recruiting

Clinical Trial Summary

The objective of this randomized cross-over trial is to evaluate whether Heparin based wet suction technique, compared with dry suction technique, shall present a higher quality tissue core by using quantitative macroscopic and microscopic scale.

Clinical Trial Description

Background & aim Endoscopic ultrasound guided fine needle biopsy (EUS-FNB) is the main tool for tissue acquisition and pathological diagnosis of pancreatic solid mass because of its superior accuracy and lower complication rate compared to CT-guided biopsy. However, the tissue adequacy and diagnostic yield remained unsatisfactory for 2 reasons. First, the conventional dry suction technique (DST) often get small tissue and 3 or more needle passes (i.e. biopsies) are required to obtain enough specimen. Second, blood contamination of the acquired tissue interfered with microscopic examination. Investigator aim to develop a novel technique to improve tissue acquisition within a fewer needle passes and avoid blood contamination by using heparin-based modified wet suction (H-MWST). Methods This study will be a randomized crossover clinical trial. Patients with pancreatic solid mass indicated for EUS FNB will be enrolled. EUS FNB will be done by one experienced endoscopists in National Cheng Kung University Hospital. Patients will be randomized in a 1:1 ratio to receive EUS FNB with either dry suction technique (DST) or H-MWST first for the initial 2 needle passes, and then crossover to another suction technique for a total of 4 needle passes. The obtained tissue of each needle pass will be sent separately and examined by a pathologist who is unaware of the procedure order. Procedure related complications will be recorded. The primary outcome will be the acquired tissue quality quantified comparison. The secondary outcome will be the overall diagnostic yield, the specimen adequacy, and complication rate by each suction technique. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04707560
Study type	Interventional
Source	National Cheng-Kung University Hospital
Contact	MengYing Lin, M.D.
Phone	886-6-2353535
Email	mikepjy@hotmail.com
Status	Recruiting
Phase	N/A
Start date	January 1, 2020
Completion date	December 31, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms