Pancreas NeoplasmNCT04841616
Multicentered Prospective Randomized Controlled Trial For Solid Pancreatic Lesions
A study testing Endoscopic Ultrasound -Guided Fine Needle Biopsy and Contrast-Enhanced Harmonic Endoscopic Ultrasound in people with Pancreas Neoplasm, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreas Neoplasm
- What is being tested?
- Endoscopic Ultrasound -Guided Fine Needle Biopsy and Contrast-Enhanced Harmonic Endoscopic Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter.
Who cannot join
- with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy
- who cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Surgery; The Chinese University of Hong Kong
Hong Kong
Charing C Chong, MBChB, 852-26321496, Chongcn@surgery.cuhk.edu.hk
Charing C Chong, MBChB
About this study
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
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.
Read the 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.
- Conditions
- Pancreas Neoplasm
- Being tested
- Endoscopic Ultrasound -Guided Fine Needle Biopsy, Contrast-Enhanced Harmonic Endoscopic Ultrasound
- Keywords
- Contrast-Enhanced EUS, FNB, Solid Pancreatic Lesions
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound -Guided Fine Needle BiopsyProcedure or surgery
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 UltrasoundProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Contrast-enhanced EUS (CH-EUS) Arm | Experimental | 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. Receives: Procedure: Contrast-Enhanced Harmonic Endoscopic Ultrasound |
| Conventional EUS Arm | Active comparator | 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 Receives: Procedure: Endoscopic Ultrasound -Guided Fine Needle Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate
Measured: up to 6 months
Secondary outcomes (5)
sensitivity
Measured: up to 6 months
specificity
Measured: up to 6 months
procedural time
minute
Measured: within 1 day
procedure-related complications
Bleeding, perforation, etc
Measured: up to 6 months
the need to repeat procedure
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pancreas NeoplasmStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charing Chong, MD, Chinese University of Hong Kong
- Investigators
- Ching Ning Chong, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841616
- Sponsor's protocol ID
- CREC2020.496
- Status last verified
- Feb 2023
- First submitted
- 30 Mar 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24550162Aadam AA, Wani S, Amick A, Shah JN, Bhat YM, Hamerski CM, Klapman JB, Muthusamy VR, Watson RR, Rademaker AW, Keswani RN, Keefer L, Das A, Komanduri S. A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy. Endosc Int Open. 2016 May;4(5):E497-505. doi: 10.1055/s-0042-106958.
PubMed 27227104Lee 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.
PubMed 25098611Iwashita T, Yasuda I, Mukai T, Doi S, Nakashima M, Uemura S, Mabuchi M, Shimizu M, Hatano Y, Hara A, Moriwaki H. Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during EUS-guided FNA using a 19-gauge needle for solid lesions: a single-center prospective pilot study (MOSE study). Gastrointest Endosc. 2015 Jan;81(1):177-85. doi: 10.1016/j.gie.2014.08.040. Epub 2014 Oct 29.
PubMed 25440688Seicean 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.
PubMed 26274382Fuccio L, Larghi A. Endoscopic ultrasound-guided fine needle aspiration: How to obtain a core biopsy? Endosc Ultrasound. 2014 Apr;3(2):71-81. doi: 10.4103/2303-9027.123011.
PubMed 24955336Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
PubMed 21420083Yang MJ, Yim H, Hwang JC, Lee D, Kim YB, Lim SG, Kim SS, Kang JK, Yoo BM, Kim JH. Endoscopic ultrasound-guided sampling of solid pancreatic masses: 22-gauge aspiration versus 25-gauge biopsy needles. BMC Gastroenterol. 2015 Sep 29;15:122. doi: 10.1186/s12876-015-0352-9.
PubMed 26419845Kin T, Katanuma A, Yane K, Takahashi K, Osanai M, Takaki R, Matsumoto K, Gon K, Matsumori T, Tomonari A, Maguchi H, Shinohara T, Nojima M. Diagnostic ability of EUS-FNA for pancreatic solid lesions with conventional 22-gauge needle using the slow pull technique: a prospective study. Scand J Gastroenterol. 2015 Jul;50(7):900-7. doi: 10.3109/00365521.2014.983155. Epub 2015 Mar 2.
PubMed 25732902Teoh AYB, Serna C, Penas I, Chong CCN, Perez-Miranda M, Ng EKW, Lau JYW. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy. 2017 Feb;49(2):130-138. doi: 10.1055/s-0042-119036. Epub 2016 Nov 22.
PubMed 27875855Teoh AY, Ng EK, Chan SM, Lai M, Moran S, Binmoeller KF, Moon JH, Ho KY. Ex vivo comparison of the lumen-apposing properties of EUS-specific stents (with video). Gastrointest Endosc. 2016 Jul;84(1):62-8. doi: 10.1016/j.gie.2015.11.041. Epub 2015 Dec 10.
PubMed 26684601Teoh AYB, Chong CCN, Leung WW, Chan SKC, Tse YK, Ng EKW, Lai PBS, Wu JCY, Lau JYW. Electroacupuncture-reduced sedative and analgesic requirements for diagnostic EUS: a prospective, randomized, double-blinded, sham-controlled study. Gastrointest Endosc. 2018 Feb;87(2):476-485. doi: 10.1016/j.gie.2017.07.029. Epub 2017 Jul 24.
PubMed 28750840Chong CCN, Tang RSY, Wong JCT, Chan AWH, Teoh AYB. Endoscopic ultrasound of pancreatic lesions. J Vis Surg. 2016 Jul 22;2:119. doi: 10.21037/jovs.2016.07.10. eCollection 2016.
PubMed 29399505Teoh AY, Chong CC, Chan AW, Lau JY. EUS-guided alcohol injection of pancreatic neuroendocrine tumor. Gastrointest Endosc. 2015 Jul;82(1):167. doi: 10.1016/j.gie.2015.01.047. Epub 2015 Apr 22. No abstract available.
PubMed 25910658Chong CCN, Teoh AYB, Tang RSY, Chan AWH, Ng EKW, Lai PBS. EUS-FNA using 22G nitinol or ProCore needles without on-site cytopathology. Endosc Ultrasound. 2018 Jan-Feb;7(1):56-60. doi: 10.4103/eus.eus_113_17.
PubMed 29451170
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04841616
- Acronym / sponsor ID
- CREC2020.496
- Conditions
- Pancreas Neoplasm
- Keywords
- Contrast-Enhanced EUS, FNB, Solid Pancreatic Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced EUS (CH-EUS) Arm | Experimental | Procedure: Contrast-Enhanced Harmonic Endoscopic UltrasoundAfter 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. |
| Conventional EUS Arm | Active comparator | Procedure: Endoscopic Ultrasound -Guided Fine Needle BiopsyPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter.
Key exclusion criteria (2 listed)
- with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy
- who cannot provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Ultrasound -Guided Fine Needle BiopsyPatients 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 or surgery | Conventional EUS Arm |
| Contrast-Enhanced Harmonic Endoscopic UltrasoundAfter 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. | Procedure or surgery | Contrast-enhanced EUS (CH-EUS) Arm |
Primary outcome
False negative rate
Time frame: up to 6 months
5 secondary outcomes
sensitivity
Time frame: up to 6 months
specificity
Time frame: up to 6 months
procedural time
Time frame: within 1 day
procedure-related complications
Time frame: up to 6 months
the need to repeat procedure
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Background: PubMed 24550162Strand 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.
- Background: PubMed 27227104Aadam AA, Wani S, Amick A, Shah JN, Bhat YM, Hamerski CM, Klapman JB, Muthusamy VR, Watson RR, Rademaker AW, Keswani RN, Keefer L, Das A, Komanduri S. A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy. Endosc Int Open. 2016 May;4(5):E497-505. doi: 10.1055/s-0042-106958.
- Background: PubMed 25098611Lee 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.
- Background: PubMed 25440688Iwashita T, Yasuda I, Mukai T, Doi S, Nakashima M, Uemura S, Mabuchi M, Shimizu M, Hatano Y, Hara A, Moriwaki H. Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during EUS-guided FNA using a 19-gauge needle for solid lesions: a single-center prospective pilot study (MOSE study). Gastrointest Endosc. 2015 Jan;81(1):177-85. doi: 10.1016/j.gie.2014.08.040. Epub 2014 Oct 29.
- Background: PubMed 26274382Seicean 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.
- Background: PubMed 24955336Fuccio L, Larghi A. Endoscopic ultrasound-guided fine needle aspiration: How to obtain a core biopsy? Endosc Ultrasound. 2014 Apr;3(2):71-81. doi: 10.4103/2303-9027.123011.
- Background: PubMed 21420083Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
- Background: PubMed 26419845Yang MJ, Yim H, Hwang JC, Lee D, Kim YB, Lim SG, Kim SS, Kang JK, Yoo BM, Kim JH. Endoscopic ultrasound-guided sampling of solid pancreatic masses: 22-gauge aspiration versus 25-gauge biopsy needles. BMC Gastroenterol. 2015 Sep 29;15:122. doi: 10.1186/s12876-015-0352-9.
- Background: PubMed 25732902Kin T, Katanuma A, Yane K, Takahashi K, Osanai M, Takaki R, Matsumoto K, Gon K, Matsumori T, Tomonari A, Maguchi H, Shinohara T, Nojima M. Diagnostic ability of EUS-FNA for pancreatic solid lesions with conventional 22-gauge needle using the slow pull technique: a prospective study. Scand J Gastroenterol. 2015 Jul;50(7):900-7. doi: 10.3109/00365521.2014.983155. Epub 2015 Mar 2.
- Background: PubMed 27875855Teoh AYB, Serna C, Penas I, Chong CCN, Perez-Miranda M, Ng EKW, Lau JYW. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy. 2017 Feb;49(2):130-138. doi: 10.1055/s-0042-119036. Epub 2016 Nov 22.
- Background: PubMed 26684601Teoh AY, Ng EK, Chan SM, Lai M, Moran S, Binmoeller KF, Moon JH, Ho KY. Ex vivo comparison of the lumen-apposing properties of EUS-specific stents (with video). Gastrointest Endosc. 2016 Jul;84(1):62-8. doi: 10.1016/j.gie.2015.11.041. Epub 2015 Dec 10.
- Background: PubMed 28750840Teoh AYB, Chong CCN, Leung WW, Chan SKC, Tse YK, Ng EKW, Lai PBS, Wu JCY, Lau JYW. Electroacupuncture-reduced sedative and analgesic requirements for diagnostic EUS: a prospective, randomized, double-blinded, sham-controlled study. Gastrointest Endosc. 2018 Feb;87(2):476-485. doi: 10.1016/j.gie.2017.07.029. Epub 2017 Jul 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching Ning Chong principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound -Guided Fine Needle Biopsy and Contrast-Enhanced Harmonic Endoscopic Ultrasound in people with Pancreas Neoplasm, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching Ning Chong (35051496, chongcn@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False negative rate (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841616, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.