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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04841616
Other study ID # CREC2020.496
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date June 30, 2025

Study information

Verified date February 2023
Source Chinese University of Hong Kong
Contact Ching Ning Chong
Phone 35051496
Email chongcn@surgery.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Endoscopic ultrasound (EUS) is an indispensable tool for tissue acquisition for pancreatic lesions. Fine needle aspiration (FNA) is once considered as the first line diagnostic method especially when rapid on-site evaluation (ROSE) by cytopathologist is available. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. Furthermore, ROSE is not available in many endoscopic centres due to limited resources. Endosonographers around the world, are discovering methods to overcome the limitations, including the use of new on-site evaluation technique by endoscopists, new fine-needle biopsy (FNB) needles, contrast-enhanced harmonic EUS-guided FNB. In this study, the investigators propose to compare the diagnostic performance between contrast-enhanced EUS-guided FNB versus conventional EUS-guided FNB technique with an aim to define the best EUS-guided tissue acquisition technique in the absence of ROSE. Results obtained from this research is expected to have significant impact in providing new insights on the best EUS-guided tissue acquisition method. It may replace FNA with ROSE as the gold standard for EUS-guided tissue acquisition in an affordable manner. It will also save the patients from unnecessary procedures and fasten the treatment pathways.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic Ultrasound -Guided Fine Needle Biopsy
Patients will undergo EUS FNB with the 22-gauge FNB needle (Acquire®, Boston Scientific Natick, MA). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of = 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed.
Contrast-Enhanced Harmonic Endoscopic Ultrasound
After initial evaluation, 2.5ml of second-generation contrast media, SonoVueTM (Bracco, Ceriano Laghetto, Italy), will be injected. After infusion, the point of puncture will be determined when the parenchyma of the pancreas was enhanced. The contrast-enhanced area was identified and then the biopsy was directed toward that area, while avoiding unenhanced (i.e. necrotic) areas and not changing the target lesion. Rest of the procedure is identical with that in conventional EUS arm.

Locations

Country Name City State
Hong Kong Department of Surgery; The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (15)

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Outcome

Type Measure Description Time frame Safety issue
Primary False negative rate up to 6 months
Secondary sensitivity up to 6 months
Secondary specificity up to 6 months
Secondary procedural time minute within 1 day
Secondary procedure-related complications Bleeding, perforation, etc up to 6 months
Secondary the need to repeat procedure up to 6 months
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