Pancreatic NeoplasmsNCT04877340
Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions
A study testing needle punction in people with Pancreatic Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. 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?
- needle punction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Nov 2020to Apr 2023
- 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
- solid pancreatic lesion larger than 15 mm
Who cannot join
- pancreatic cystic lesion
- lesion not detected in EUS
- abnormal coagulation parameters (INR> 2, platelet count < 50,000)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ICESP
São Paulo, São Paulo, 01246-000
ICESP
FAUZE MALUF-FILHO, PHD
About this study
Official title: Prospective Randomized Study Comparing the 25-gauge Franseen Needle and the 25-gauge Standard Needle for EUS-guided Fine-needle Sampling of Solid Pancreatic Lesions Without Rapid on Site Evaluation
This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.
Read the detailed description
This is a randomized trial conducted at a unique center. The aim of this study is to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.
Patients with a suspected solid pancreatic lesion larger than 15 mm, identified by CT or MRI and referred to EUS-guided sampling will be eligible for inclusion. Patients will be excluded in case of cystic lesion, or the lesion was not detected in EUS, or if the coagulation parameters are abnormal (INR> 2, platelet count < 50,000). The pancreatic mass will be puncture, for expert endoscopist, firstly with a needle according to randomization, followed by another one. Will be make a touch print with the specimen obtained with the needles and, subsequently, all the specimen will be put in formaldehyde solution for cell-block analysis.
Diagnostic yield of cell block will be defined as enough histologic tissue core containing pancreatic parenchyma or tumor with dysplastic cells enough for the correct tissue diagnosis. In the presence of malignant tissue in core specimens, it will be calculated the proportion of the area positive for malignancy compared to the total area of the core and then the each needle yield will be defined.
- Conditions
- Pancreatic Neoplasms
- Being tested
- needle punction
- Keywords
- accuracy, pancreatic cancer, endoscopic ultrasound-guided
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle punctionDevice
EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge
| Study group | Role | What they receive |
|---|---|---|
| Standard FNA 22G needle | Other | The pancreatic mass will be puncture, for expert endoscopist, with a standard FNA 22G needle Receives: Device: needle punction |
| Franseen 22G needle | Experimental | The pancreatic mass will be puncture, for expert endoscopist, with a FNB 22G needle. The sequence of the use of needles will be randomized. Receives: Device: needle punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the diagnostic yield
compare the diagnostic yield between two EUS needles
Measured: 2 years
Secondary outcomes (3)
extra passes with each needle
number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry
Measured: 2 years
perform immunohistochemistry
need to perform immunohistochemistry to reach the result
Measured: 2 years
adverse event rate
to assess the adverse event rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start26 Nov 2020
- Primary completionNov 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- FAUZE MALUF-FILHO, PHD, Principal investigator, ICESP/FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877340
- Sponsor's protocol ID
- 26962419.3.0000.0065
- Status last verified
- May 2021
- First submitted
- 20 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madhoun MF, Wani SB, Rastogi A, Early D, Gaddam S, Tierney WM, Maple JT. The diagnostic accuracy of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis. Endoscopy. 2013;45(2):86-92. doi: 10.1055/s-0032-1325992. Epub 2013 Jan 10.
PubMed 23307148Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.
PubMed 19117242Wani S, Early D, Kunkel J, Leathersich A, Hovis CE, Hollander TG, Kohlmeier C, Zelenka C, Azar R, Edmundowicz S, Collins B, Liu J, Hall M, Mullady D. Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial. Gastrointest Endosc. 2012 Aug;76(2):328-35. doi: 10.1016/j.gie.2012.03.1395. Epub 2012 Jun 12.
PubMed 22695205Itoi T, Sofuni A, Itokawa F, Irisawa A, Khor CJ, Rerknimitr R. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc. 2011 May;23 Suppl 1:17-21. doi: 10.1111/j.1443-1661.2011.01132.x.
PubMed 21535194Levy MJ. Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and problems. Pancreatology. 2007;7(2-3):163-6. doi: 10.1159/000104240. Epub 2007 Jun 21.
PubMed 17592229Fabbri C, Polifemo AM, Luigiano C, Cennamo V, Baccarini P, Collina G, Fornelli A, Macchia S, Zanini N, Jovine E, Fiscaletti M, Alibrandi A, D'Imperio N. Endoscopic ultrasound-guided fine needle aspiration with 22- and 25-gauge needles in solid pancreatic masses: a prospective comparative study with randomisation of needle sequence. Dig Liver Dis. 2011 Aug;43(8):647-52. doi: 10.1016/j.dld.2011.04.005. Epub 2011 May 17.
PubMed 21592873Wang Y, Chen Q, Wang J, Wu X, Duan Y, Yin P, Guo Q, Hou W, Cheng B. Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial. Trials. 2018 Jan 17;19(1):45. doi: 10.1186/s13063-017-2380-y.
PubMed 29343303Kim HJ, Jung YS, Park JH, Park DI, Cho YK, Sohn CI, Jeon WK, Kim BI, Choi KY, Ryu S. Endosonographer's macroscopic evaluation of EUS-FNAB specimens after interactive cytopathologic training: a single-center prospective validation cohort study. Surg Endosc. 2016 Oct;30(10):4184-92. doi: 10.1007/s00464-015-4727-3. Epub 2016 Jan 7.
PubMed 26743106Sadaf S, Loya A, Akhtar N, Yusuf MA. Role of endoscopic ultrasound-guided-fine needle aspiration biopsy in the diagnosis of lymphoma of the pancreas: A clinicopathological study of nine cases. Cytopathology. 2017 Dec;28(6):536-541. doi: 10.1111/cyt.12442. Epub 2017 Jul 24.
PubMed 28737285Mohanty SK, Pradhan D, Sharma S, Sharma A, Patnaik N, Feuerman M, Bonasara R, Boyd A, Friedel D, Stavropoulos S, Gupta M. Endoscopic ultrasound guided fine-needle aspiration: What variables influence diagnostic yield? Diagn Cytopathol. 2018 Apr;46(4):293-298. doi: 10.1002/dc.23883. Epub 2017 Dec 27.
PubMed 29280329Vilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available.
PubMed 1568614Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12.
PubMed 21483464Iglesias-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 21420083Bang JY, Hebert-Magee S, Hasan MK, Navaneethan U, Hawes R, Varadarajulu S. Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment. Dig Endosc. 2017 May;29(3):338-346. doi: 10.1111/den.12769. Epub 2016 Dec 20.
PubMed 27878861
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the 25-gauge Franseen Needle and the 25-gauge Standard Needle for EUS-guided Fine-needle Sampling of Solid Pancreatic Lesions Without Rapid on Site Evaluation
- ClinicalTrials.gov ID
- NCT04877340
- Acronym / sponsor ID
- 26962419.3.0000.0065
- Conditions
- Pancreatic Neoplasms
- Keywords
- accuracy, pancreatic cancer, endoscopic ultrasound-guided
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 7 May 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.
This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.
Detailed description
This is a randomized trial conducted at a unique center. The aim of this study is to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.
Patients with a suspected solid pancreatic lesion larger than 15 mm, identified by CT or MRI and referred to EUS-guided sampling will be eligible for inclusion. Patients will be excluded in case of cystic lesion, or the lesion was not detected in EUS, or if the coagulation parameters are abnormal (INR> 2, platelet count < 50,000). The pancreatic mass will be puncture, for expert endoscopist, firstly with a needle according to randomization, followed by another one. Will be make a touch print with the specimen obtained with the needles and, subsequently, all the specimen will be put in formaldehyde solution for cell-block analysis.
Diagnostic yield of cell block will be defined as enough histologic tissue core containing pancreatic parenchyma or tumor with dysplastic cells enough for the correct tissue diagnosis. In the presence of malignant tissue in core specimens, it will be calculated the proportion of the area positive for malignancy compared to the total area of the core and then the each needle yield will be defined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard FNA 22G needle | Other | Device: needle punctionThe pancreatic mass will be puncture, for expert endoscopist, with a standard FNA 22G needle |
| Franseen 22G needle | Experimental | Device: needle punctionThe pancreatic mass will be puncture, for expert endoscopist, with a FNB 22G needle. The sequence of the use of needles will be randomized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- solid pancreatic lesion larger than 15 mm
Key exclusion criteria (3 listed)
- pancreatic cystic lesion
- lesion not detected in EUS
- abnormal coagulation parameters (INR> 2, platelet count < 50,000)
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 |
|---|---|---|
| needle punctionEUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge | Device | Franseen 22G needle, Standard FNA 22G needle |
Primary outcome
Compare the diagnostic yield
Time frame: 2 years
compare the diagnostic yield between two EUS needles
3 secondary outcomes
extra passes with each needle
Time frame: 2 years
perform immunohistochemistry
Time frame: 2 years
adverse event rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Background: PubMed 23307148Madhoun MF, Wani SB, Rastogi A, Early D, Gaddam S, Tierney WM, Maple JT. The diagnostic accuracy of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis. Endoscopy. 2013;45(2):86-92. doi: 10.1055/s-0032-1325992. Epub 2013 Jan 10.
- Background: PubMed 19117242Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.
- Background: PubMed 22695205Wani S, Early D, Kunkel J, Leathersich A, Hovis CE, Hollander TG, Kohlmeier C, Zelenka C, Azar R, Edmundowicz S, Collins B, Liu J, Hall M, Mullady D. Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial. Gastrointest Endosc. 2012 Aug;76(2):328-35. doi: 10.1016/j.gie.2012.03.1395. Epub 2012 Jun 12.
- Background: PubMed 21535194Itoi T, Sofuni A, Itokawa F, Irisawa A, Khor CJ, Rerknimitr R. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc. 2011 May;23 Suppl 1:17-21. doi: 10.1111/j.1443-1661.2011.01132.x.
- Background: PubMed 17592229Levy MJ. Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and problems. Pancreatology. 2007;7(2-3):163-6. doi: 10.1159/000104240. Epub 2007 Jun 21.
- Background: PubMed 21592873Fabbri C, Polifemo AM, Luigiano C, Cennamo V, Baccarini P, Collina G, Fornelli A, Macchia S, Zanini N, Jovine E, Fiscaletti M, Alibrandi A, D'Imperio N. Endoscopic ultrasound-guided fine needle aspiration with 22- and 25-gauge needles in solid pancreatic masses: a prospective comparative study with randomisation of needle sequence. Dig Liver Dis. 2011 Aug;43(8):647-52. doi: 10.1016/j.dld.2011.04.005. Epub 2011 May 17.
- Background: PubMed 29343303Wang Y, Chen Q, Wang J, Wu X, Duan Y, Yin P, Guo Q, Hou W, Cheng B. Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial. Trials. 2018 Jan 17;19(1):45. doi: 10.1186/s13063-017-2380-y.
- Background: PubMed 26743106Kim HJ, Jung YS, Park JH, Park DI, Cho YK, Sohn CI, Jeon WK, Kim BI, Choi KY, Ryu S. Endosonographer's macroscopic evaluation of EUS-FNAB specimens after interactive cytopathologic training: a single-center prospective validation cohort study. Surg Endosc. 2016 Oct;30(10):4184-92. doi: 10.1007/s00464-015-4727-3. Epub 2016 Jan 7.
- Background: PubMed 28737285Sadaf S, Loya A, Akhtar N, Yusuf MA. Role of endoscopic ultrasound-guided-fine needle aspiration biopsy in the diagnosis of lymphoma of the pancreas: A clinicopathological study of nine cases. Cytopathology. 2017 Dec;28(6):536-541. doi: 10.1111/cyt.12442. Epub 2017 Jul 24.
- Background: PubMed 29280329Mohanty SK, Pradhan D, Sharma S, Sharma A, Patnaik N, Feuerman M, Bonasara R, Boyd A, Friedel D, Stavropoulos S, Gupta M. Endoscopic ultrasound guided fine-needle aspiration: What variables influence diagnostic yield? Diagn Cytopathol. 2018 Apr;46(4):293-298. doi: 10.1002/dc.23883. Epub 2017 Dec 27.
- Results publication: PubMed 1568614Vilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available.
- Results publication: PubMed 21483464Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12.
- 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.
FAUZE MALUF-FILHO, PHD principal investigator
ICESP/FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needle punction in people with Pancreatic Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 3 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 7 May 2021. 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 Brazil. 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 FAUZE MALUF-FILHO, PHD (+55 (11)38932000, fauze.maluf@terra.om.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the diagnostic yield (time frame: 2 years). 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 NCT04877340, which also lists 14 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 7 May 2021.