Pancreatic NeoplasmsNCT04085055
Fine Needle Biopsy of Solid Pancreatic Mass Lesions
A study testing Solid pancreatic mass lesion biopsy in people with Pancreatic Neoplasms, run by AdventHealth at 1 site in United States.
Trial summary
This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Solid pancreatic mass lesion biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
- Able and willing to provide written or verbal consent
- ≥ 18 years old
- Able to undergo conscious sedation for EUS procedure
Who cannot join
- <18 years old
- Unable to obtain informed consent from the patient
- Medically unfit for sedation
- Pregnant patients
- No pancreatic mass lesions visualized on EUS
- Irreversible coagulopathy as determined by platelet count < 50,000/microL or International Normalized Ratio (INR) > 1.5
- Unable to stop anti-platelet agents prior to the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
About this study
Official title: Randomized Trial Comparing Fine Needle Biopsy Needles and Different Techniques for Endoscopic-guided Fine Needle Biopsy of Solid Pancreatic Mass Lesions
This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.
Read the detailed description
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failure of EUS-FNA can be due to inadequate targeting, inexperience of the endoscopist/pathologist, or necrotic or fibrotic tumors in which viable cells are difficult to obtain. The cellularity and architectural representation of the sample can also be determined by the needle used and its specific features. Recently, new needles known as "fine needle biopsy (FNB)" needles have become available that are specially designed to promote the collection of core tissue by unique designs of their needle tips. The advantages of FNB over FNA needles are that (a) the quality of tissue procured is superior: FNA needles yield cytology whereas FNB needles yield histology (b) molecular marker analysis can be performed more reliably on histology samples than cytology aspirates and (c) as histological tissue is greater in quantity than cytological aspirates, a quicker diagnosis with fewer passes can be established by histology than cytology.
Four different types of FNB needles are currently available - reverse-bevel tip (EchoTip ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), Menghini-tip (EZ shot, Olympus America, Center Valley, PA), Franseen tip (Acquire, Boston Scientific Corporation, Natick, MA) and fork-tip (SharkCore, Medtronic Corporation/Covidien, Newton, MA) needles, each with unique tip designs to facilitate procurement of histological core tissue. Although we have previously compared in randomized trials the diagnostic yield of Franseen and fork-tip FNB needles and have shown the two needles to be equivalent, there are currently no randomized trials directly comparing all four FNB needle types. EUS-guided tissue acquisition can also be performed using different techniques, including the use of suction, no use of suction and the stylet retraction technique. There are currently no studies comparing these different tissue acquisition techniques using the different FNB needles and no study has demonstrated the best technique for FNB.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Solid pancreatic mass lesion biopsy
- Keywords
- pancreatic mass, pancreatic solid mass, pancreatic lesion
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid pancreatic mass lesion biopsyDiagnostic test
Also called biopsy, fine needle biopsy, fine needle aspiration
The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| 22 Gauge FNB Needle - ProCore | Active comparator | The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions. Receives: Diagnostic Test: Solid pancreatic mass lesion biopsy |
| 22 Gauge FNB Needle - Acquire | Active comparator | The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions. Receives: Diagnostic Test: Solid pancreatic mass lesion biopsy |
| 22 Gauge FNB Needle - SharkCore | Active comparator | The 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions. Receives: Diagnostic Test: Solid pancreatic mass lesion biopsy |
| 22 Gauge FNB needle - EZ Shot 3 Plus | Active comparator | The 22 Gauge FNB Needle - EZ Shot 3 Plus will be used to biopsy solid pancreatic mass lesions. Receives: Diagnostic Test: Solid pancreatic mass lesion biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of cellularity in biopsy sample
Compare the degree of cellularity of the obtained tissue in the biopsy sample between the four FNB needles in patients undergoing EUS-guided sampling of pancreatic masses using the three different sampling techniques. Cellularity is defined as the proportion of core tissue to total specimen area.
Measured: 3 days
Secondary outcomes (6)
Diagnostic adequacy of the biopsy sample
Documentation of the presence of adequate tissue material (pancreatic parenchyma and tumor if applicable) in the biopsy sample.
Measured: 1 day
Specimen bloodiness in biopsy sample
Measured as the area of bloodiness in the biopsy sample, with calculation as a percentage in the microscopic field.
Measured: 1 day
Presence of crush artefact in biopsy sample
Documenting the presence or absence of crush artefact in the biopsy sample. If present, it is measured as the area of artefact in biopsy sample, with calculation as a percentage in relation to the total sample area.
Measured: 1 day
Technical failure
Measured as the inability to successfully perform the fine needle biopsy using the assigned needle, due to any needle dysfunction.
Measured: 1 day
Adverse events
The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure or the underlying disease.
Measured: 7 days, 30 days, and 6 months
Diagnostic operating characteristics
Compare the diagnostic operating characteristics of the biopsy sample and detection of neoplasia (defined as sensitivity, specificity, negative predictive value, positive predictive value and accuracy) between the four FNB needles in patients undergoing EUS-guided sampling of pancreatic masses using the three different sampling techniques
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start9 Sep 2019
- Primary completion25 Jun 2020
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a randomized trial comparing four types of FNB needles and three sampling techniques. Patients will be randomized to one of the four different FNB needles. All patients will then undergo FNB using the specified needle and all three sampling techniques (one pass per technique using the assigned needle).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085055
- Sponsor's protocol ID
- 1469116
- Status last verified
- Aug 2020
- First submitted
- 9 Sep 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ngamruengphong S, Li F, Zhou Y, Chak A, Cooper GS, Das A. EUS and survival in patients with pancreatic cancer: a population-based study. Gastrointest Endosc. 2010 Jul;72(1):78-83, 83.e1-2. doi: 10.1016/j.gie.2010.01.072.
PubMed 20620274Othman MO, Wallace MB. The role of endoscopic ultrasonography in the diagnosis and management of pancreatic cancer. Gastroenterol Clin North Am. 2012 Mar;41(1):179-88. doi: 10.1016/j.gtc.2011.12.014. Epub 2012 Jan 16.
PubMed 22341257Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.
PubMed 22248600Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.
PubMed 15100946Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy. 2016 Apr;48(4):339-49. doi: 10.1055/s-0034-1393354. Epub 2015 Nov 12.
PubMed 26561917Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. EUS-guided fine needle biopsy of pancreatic masses can yield true histology. Gut. 2018 Dec;67(12):2081-2084. doi: 10.1136/gutjnl-2017-315154. Epub 2017 Oct 7. No abstract available.
PubMed 28988195Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.
PubMed 29305893Lee KY, Cho HD, Hwangbo Y, Yang JK, Han SJ, Choi HJ, Lee YN, Cha SW, Moon JH, Cho YD, Park SH, Lee TH. Efficacy of 3 fine-needle biopsy techniques for suspected pancreatic malignancies in the absence of an on-site cytopathologist. Gastrointest Endosc. 2019 Apr;89(4):825-831.e1. doi: 10.1016/j.gie.2018.10.042. Epub 2018 Nov 4.
PubMed 30403966Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.
PubMed 29272906Nakai Y, Isayama H, Chang KJ, Yamamoto N, Hamada T, Uchino R, Mizuno S, Miyabayashi K, Yamamoto K, Kawakubo K, Kogure H, Sasaki T, Hirano K, Tanaka M, Tada M, Fukayama M, Koike K. Slow pull versus suction in endoscopic ultrasound-guided fine-needle aspiration of pancreatic solid masses. Dig Dis Sci. 2014 Jul;59(7):1578-85. doi: 10.1007/s10620-013-3019-9. Epub 2014 Jan 16.
PubMed 24429514Chow, S.C.; Shao, J.; Wang, H. 2008. Sample Size Calculations in Clinical Research, 2nd Edition. Chapman & Hall/CRC. Boca Raton, FL. Pages 99-100.
Young Bang J, Krall K, Jhala N, Singh C, Tejani M, Arnoletti JP, Navaneethan U, Hawes R, Varadarajulu S. Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients With Pancreatic Masses in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Apr;19(4):825-835.e7. doi: 10.1016/j.cgh.2020.06.042. Epub 2020 Jul 8.
PubMed 32652307
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Fine Needle Biopsy Needles and Different Techniques for Endoscopic-guided Fine Needle Biopsy of Solid Pancreatic Mass Lesions
- ClinicalTrials.gov ID
- NCT04085055
- Acronym / sponsor ID
- 1469116
- Conditions
- Pancreatic Neoplasms
- Keywords
- pancreatic mass, pancreatic solid mass, pancreatic lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Sep 2019 (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.
This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.
Detailed description
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failure of EUS-FNA can be due to inadequate targeting, inexperience of the endoscopist/pathologist, or necrotic or fibrotic tumors in which viable cells are difficult to obtain. The cellularity and architectural representation of the sample can also be determined by the needle used and its specific features. Recently, new needles known as "fine needle biopsy (FNB)" needles have become available that are specially designed to promote the collection of core tissue by unique designs of their needle tips. The advantages of FNB over FNA needles are that (a) the quality of tissue procured is superior: FNA needles yield cytology whereas FNB needles yield histology (b) molecular marker analysis can be performed more reliably on histology samples than cytology aspirates and (c) as histological tissue is greater in quantity than cytological aspirates, a quicker diagnosis with fewer passes can be established by histology than cytology.
Four different types of FNB needles are currently available - reverse-bevel tip (EchoTip ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), Menghini-tip (EZ shot, Olympus America, Center Valley, PA), Franseen tip (Acquire, Boston Scientific Corporation, Natick, MA) and fork-tip (SharkCore, Medtronic Corporation/Covidien, Newton, MA) needles, each with unique tip designs to facilitate procurement of histological core tissue. Although we have previously compared in randomized trials the diagnostic yield of Franseen and fork-tip FNB needles and have shown the two needles to be equivalent, there are currently no randomized trials directly comparing all four FNB needle types. EUS-guided tissue acquisition can also be performed using different techniques, including the use of suction, no use of suction and the stylet retraction technique. There are currently no studies comparing these different tissue acquisition techniques using the different FNB needles and no study has demonstrated the best technique for FNB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a randomized trial comparing four types of FNB needles and three sampling techniques. Patients will be randomized to one of the four different FNB needles. All patients will then undergo FNB using the specified needle and all three sampling techniques (one pass per technique using the assigned needle).
| Arm | Type | Receives |
|---|---|---|
| 22 Gauge FNB Needle - ProCore | Active comparator | Diagnostic Test: Solid pancreatic mass lesion biopsyThe 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions. |
| 22 Gauge FNB Needle - Acquire | Active comparator | Diagnostic Test: Solid pancreatic mass lesion biopsyThe 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions. |
| 22 Gauge FNB Needle - SharkCore | Active comparator | Diagnostic Test: Solid pancreatic mass lesion biopsyThe 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions. |
| 22 Gauge FNB needle - EZ Shot 3 Plus | Active comparator | Diagnostic Test: Solid pancreatic mass lesion biopsyThe 22 Gauge FNB Needle - EZ Shot 3 Plus will be used to biopsy solid pancreatic mass lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
- Able and willing to provide written or verbal consent
- ≥ 18 years old
- Able to undergo conscious sedation for EUS procedure
Key exclusion criteria (7 listed)
- <18 years old
- Unable to obtain informed consent from the patient
- Medically unfit for sedation
- Pregnant patients
- No pancreatic mass lesions visualized on EUS
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 |
|---|---|---|
| Solid pancreatic mass lesion biopsyAlso: biopsy, fine needle biopsy, fine needle aspirationThe needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis. | Diagnostic test | 22 Gauge FNB Needle - Acquire, 22 Gauge FNB Needle - ProCore, 22 Gauge FNB Needle - SharkCore, 22 Gauge FNB needle - EZ Shot 3 Plus |
Primary outcome
Degree of cellularity in biopsy sample
Time frame: 3 days
Compare the degree of cellularity of the obtained tissue in the biopsy sample between the four FNB needles in patients undergoing EUS-guided sampling of pancreatic masses using the three different sampling techniques. Cellularity is defined as the proportion of core tissue to total specimen area.
6 secondary outcomes
Diagnostic adequacy of the biopsy sample
Time frame: 1 day
Specimen bloodiness in biopsy sample
Time frame: 1 day
Presence of crush artefact in biopsy sample
Time frame: 1 day
Technical failure
Time frame: 1 day
Adverse events
Time frame: 7 days, 30 days, and 6 months
Diagnostic operating characteristics
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Background: PubMed 20620274Ngamruengphong S, Li F, Zhou Y, Chak A, Cooper GS, Das A. EUS and survival in patients with pancreatic cancer: a population-based study. Gastrointest Endosc. 2010 Jul;72(1):78-83, 83.e1-2. doi: 10.1016/j.gie.2010.01.072.
- Background: PubMed 22341257Othman MO, Wallace MB. The role of endoscopic ultrasonography in the diagnosis and management of pancreatic cancer. Gastroenterol Clin North Am. 2012 Mar;41(1):179-88. doi: 10.1016/j.gtc.2011.12.014. Epub 2012 Jan 16.
- Background: PubMed 22248600Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.
- Background: PubMed 15100946Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.
- Background: PubMed 26561917Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy. 2016 Apr;48(4):339-49. doi: 10.1055/s-0034-1393354. Epub 2015 Nov 12.
- Background: PubMed 28988195Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. EUS-guided fine needle biopsy of pancreatic masses can yield true histology. Gut. 2018 Dec;67(12):2081-2084. doi: 10.1136/gutjnl-2017-315154. Epub 2017 Oct 7. No abstract available.
- Background: PubMed 29305893Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.
- Background: PubMed 30403966Lee KY, Cho HD, Hwangbo Y, Yang JK, Han SJ, Choi HJ, Lee YN, Cha SW, Moon JH, Cho YD, Park SH, Lee TH. Efficacy of 3 fine-needle biopsy techniques for suspected pancreatic malignancies in the absence of an on-site cytopathologist. Gastrointest Endosc. 2019 Apr;89(4):825-831.e1. doi: 10.1016/j.gie.2018.10.042. Epub 2018 Nov 4.
- Background: PubMed 29272906Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.
- Background: PubMed 24429514Nakai Y, Isayama H, Chang KJ, Yamamoto N, Hamada T, Uchino R, Mizuno S, Miyabayashi K, Yamamoto K, Kawakubo K, Kogure H, Sasaki T, Hirano K, Tanaka M, Tada M, Fukayama M, Koike K. Slow pull versus suction in endoscopic ultrasound-guided fine-needle aspiration of pancreatic solid masses. Dig Dis Sci. 2014 Jul;59(7):1578-85. doi: 10.1007/s10620-013-3019-9. Epub 2014 Jan 16.
- BackgroundChow, S.C.; Shao, J.; Wang, H. 2008. Sample Size Calculations in Clinical Research, 2nd Edition. Chapman & Hall/CRC. Boca Raton, FL. Pages 99-100.
- Derived from this study: PubMed 32652307Young Bang J, Krall K, Jhala N, Singh C, Tejani M, Arnoletti JP, Navaneethan U, Hawes R, Varadarajulu S. Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients With Pancreatic Masses in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Apr;19(4):825-835.e7. doi: 10.1016/j.cgh.2020.06.042. Epub 2020 Jul 8.
Related trials for Pancreatic Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Shyam Varadarajulu, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solid pancreatic mass lesion biopsy in people with Pancreatic Neoplasms, run by AdventHealth at 1 site in United States.
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 4 inclusion and 7 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 5 Aug 2020. 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 United States. 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 Shyam Varadarajulu, MD (407.303.2750, shyam.varadarajulu.md@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of cellularity in biopsy sample (time frame: 3 days). 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 NCT04085055, which also lists 12 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 5 Aug 2020.