MedTrace Logo

Multicentered Prospective Randomized Controlled Trial For Solid Pancreatic Lesions

NCT04841616 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-02-13

No results posted yet for this study

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.

Conditions

  • Pancreas Neoplasm

Interventions

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Ching Ning Chong · CUHK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841616 on ClinicalTrials.gov