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Multicentered Prospective Randomized Controlled Trial For Solid Pancreatic Lesions

Primary Purpose

Pancreas Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Endoscopic Ultrasound -Guided Fine Needle Biopsy
Contrast-Enhanced Harmonic Endoscopic Ultrasound
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Neoplasm focused on measuring Contrast-Enhanced EUS, FNB, Solid Pancreatic Lesions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Surgery; The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Contrast-enhanced EUS (CH-EUS) Arm

Conventional EUS Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

False negative rate

Secondary Outcome Measures

sensitivity
specificity
procedural time
minute
procedure-related complications
Bleeding, perforation, etc
the need to repeat procedure

Full Information

First Posted
March 30, 2021
Last Updated
February 9, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04841616
Brief Title
Multicentered Prospective Randomized Controlled Trial For Solid Pancreatic Lesions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasm
Keywords
Contrast-Enhanced EUS, FNB, Solid Pancreatic Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contrast-enhanced EUS (CH-EUS) Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional EUS Arm
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Ultrasound -Guided Fine Needle Biopsy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Contrast-Enhanced Harmonic Endoscopic Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
False negative rate
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
sensitivity
Time Frame
up to 6 months
Title
specificity
Time Frame
up to 6 months
Title
procedural time
Description
minute
Time Frame
within 1 day
Title
procedure-related complications
Description
Bleeding, perforation, etc
Time Frame
up to 6 months
Title
the need to repeat procedure
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching Ning Chong
Phone
35051496
Email
chongcn@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching Ning Chong
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery; The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charing C Chong, MBChB
Phone
852-26321496
Email
Chongcn@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Charing C Chong, MBChB

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24550162
Citation
Strand DS, Jeffus SK, Sauer BG, Wang AY, Stelow EB, Shami VM. EUS-guided 22-gauge fine-needle aspiration versus core biopsy needle in the evaluation of solid pancreatic neoplasms. Diagn Cytopathol. 2014 Sep;42(9):751-8. doi: 10.1002/dc.23116. Epub 2014 Feb 18.
Results Reference
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Results Reference
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PubMed Identifier
25098611
Citation
Lee YN, Moon JH, Kim HK, Choi HJ, Choi MH, Kim DC, Lee TH, Cha SW, Cho YD, Park SH. Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study. Endoscopy. 2014 Dec;46(12):1056-62. doi: 10.1055/s-0034-1377558. Epub 2014 Aug 6.
Results Reference
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25440688
Citation
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Results Reference
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PubMed Identifier
26274382
Citation
Seicean A, Badea R, Moldovan-Pop A, Vultur S, Botan EC, Zaharie T, Saftoiu A, Mocan T, Iancu C, Graur F, Sparchez Z, Seicean R. Harmonic Contrast-Enhanced Endoscopic Ultrasonography for the Guidance of Fine-Needle Aspiration in Solid Pancreatic Masses. Ultraschall Med. 2017 Apr;38(2):174-182. doi: 10.1055/s-0035-1553496. Epub 2015 Aug 14.
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Citation
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Multicentered Prospective Randomized Controlled Trial For Solid Pancreatic Lesions

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