Multicentered Prospective Randomized Controlled Trial For Solid Pancreatic Lesions

February 9, 2023 updated by: Charing Chong, MD, Chinese University of Hong Kong

Multicentered Prospective Randomized Controlled Trial On Contrast-Enhanced Harmonic Endoscopic Ultrasound (CH_EUS) Vs Conventional EUS-Guided Fine Needle Biopsy (FNB) For Solid Pancreatic Lesions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Seicean et al, in a prospective study, evaluated the diagnostic accuracy of EUS-FNA with CH-EUS using SonoVueTM versus EUS-FNA without CH-EUS. They found that the diagnostic accuracy of EUS-FNA with CH-EUS was higher than that of EUSFNA without CH-EUS (86.5% vs 78.4%). However, the difference did not reach the threshold required for statistical significance. Also, only FNA, but not FNB, was performed in this study.

The FNB needle was introduced to further improve upon EUS guided tissue sampling. It is designed to collect a larger amount of core sample tissue with preserved histological architecture for further analysis, including molecular analysis. Also the FNB needle has been shown to obtain samples with higher cellularity compared to the standard FNA needles. Compared with EUS-FNA, EUS-FNB had a better specimen adequacy, higher diagnostic accuracy, and fewer number of needle passes but no increase in complications rate.

The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen obtained by EUS for histological diagnosis. MOSE involves immediate examination of the FNB specimen for the presence of a "macroscopic visible core" (MVC), which is defined as whitish or yellowish pieces of tissue with an apparent bulk. The total length of the MVC is then measured and the optimal cut-off MVC length was 4 mm. This study demonstrated that EUS-FNB with MOSE provided comparable diagnostic yield as EUS-FNB without MOSE (92.6% vs 89.3%) with fewer numbers of passes.

Puncturing avascular or necrotic area of a tumour could be the major reason of false negative rate during EUS-guided FNB. Contrast-enhanced harmonic EUS (CH-EUS) can define avascular or necrotic area inside a tumour which may improve the false negative rate during EUS-FNB. In this study, the investigators aim to evaluate the diagnostic performance of CH-EUS-guided FNB with MOSE for solid pancreatic masses. The investigators expect the study will define the best EUS-guided tissue acquisition technique in the absence of ROSE and replace FNA with ROSE as gold standard for tissue sampling for solid pancreatic masses.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Surgery; The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter.

Exclusion Criteria:

  • with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy
  • who cannot provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Contrast-enhanced EUS (CH-EUS) Arm
After initial evaluation, 2.5ml of second-generation contrast media, SonoVue (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.
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.
ACTIVE_COMPARATOR: Conventional EUS Arm
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
False negative rate
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity
Time Frame: up to 6 months
up to 6 months
specificity
Time Frame: up to 6 months
up to 6 months
procedural time
Time Frame: within 1 day
minute
within 1 day
procedure-related complications
Time Frame: up to 6 months
Bleeding, perforation, etc
up to 6 months
the need to repeat procedure
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Ching Ning Chong, CUHK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2021

Primary Completion (ANTICIPATED)

June 30, 2024

Study Completion (ANTICIPATED)

June 30, 2025

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (ACTUAL)

April 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC2020.496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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