Solid Lesion BiopsiesNCT02048124
Study Comparing 25d ProCor Needle Versus the Standard 25g Needle for Biopsies Performed by EUS-FNA
A study testing 25g standard needle and 25d ProCor needle in people with Solid Lesion Biopsies, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological (rather than cytological) evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Lesion Biopsies
- What is being tested?
- 25g standard needle and 25d ProCor needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2014to 15 Sep 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
- Age: ≥ 18 years old
- Patients presenting with a solid lesion
- Patients for whom EUS-FNA is considered clinically indicated and safe
Who cannot join
- Age < 18 years old,
- Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis or other lesions in which a large amount of tissue will be required for diagnosis,
- Patients with significant coagulopathy (INR>1.5, platelets <50000/mm3, use of low molecular weight heparin, use of clopidogrel within 7 days of EUS), Patients presenting with cystic lesions Inability or refusal to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)
Montreal, Quebec, H2X3J4
About this study
Official title: Prospective Study Comparing the Diagnostic Yield of Solid Lesion Biopsies Performed by EUS-FNA Using the 25d ProCor Needle Versus the Standard 25g Needle.
Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a new needle named "ProCor" was developed in the hope of obtaining core samples and thus increase diagnostic yield.
Objective: In this research project, we propose to conduct a prospective trial to compare the results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor needle (25gP).
Read more
EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P).
The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),[14] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive).
Results for continuous variables will be summarized using mean ± SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.
Read the detailed description
Objectives of the study
The primary objective is to compare the diagnostic yield of biopsies performed by EUS-FNA using the 25d ProCor needle versus the standard 25g needle.
The primary outcome is the diagnostic yield defined as: sensitivity for the presence of cancer based on the analysis of EUS-FNA samples.
The secondary objectives are:
- to compare the size of the "core" samples produced by the two types of needles.
- to compare the incidence and severity of immediate complications associated with the two types of needles
Methods
Design: This a prospective clinical study for the validation of a new instrument (ProCor biopsy needle) for application to clinical medicine, namely the diagnosis of cancer.
Endoscopic procedures:
Informed consent by the patient will be obtained before each procedure by a single research assistant.
All EUS examinations will be performed under conscious sedation (midazolam, fentanyl) by one two experienced endosonographers according to the standard procedures at the CHUM and using a linear echoendoscope. , If the lesion is considered solid and EUS-FNA is considered clinically indicated and safe, the patient will be enrolled and the randomisation envelope will be opened. EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P).
EUS-FNA passes will be performed without stylet. One "needle pass" is defined as 5 strokes in 4 different areas of the lesion. The material from the first 2 needle passes (one 25S and the other 25P) will be expressed into formalin to look for core samples. Material from the next 2 needle passes (again one 25S and the other 25P) will be expressed onto slides for cytological analysis. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3).
Immediate complications will be assessed and recorded by nurses and/or physicians during the procedure as well after the procedure while the patients will be monitored in the recovery room for at least 60 minutes before discharge.
The areas which will be investigated by biopsy will be the pancreas, the retroperitoneal and/or the mediastinal lymph nodes.
Cytological and Histological analyses:
Samples from all needle passes will be stained using a standard Papanicolaou stain and analyzed by one experienced pathologist who will be blinded as to needle type. The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),[14] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive).
Diagnostic yield Diagnostic yield is defined as sensitivity for the presence of cancer based on the analysis of EUS-FNA samples. The gold standard will be the presence of cancer as defined on the basis of at least one of the following two criteria: positive cytological or histological results and malignant disease after clinical follow up (clinical worsening and radiologic evidence of progression within the 6 months following FNA).
Data collection
Clinical data will be collected prospectively and saved in a database. In addition to demographics, these will include:
- size and location (pancreas, lymph node, liver, adrenal gland, others) of the target lesion
- technical and procedure variables ( FNA path, , number of needle passes, needle visibility, ease to puncture, needle failure, cellularity, bloodiness)
- cytological diagnosis
- final diagnosis
- immediate complications. Research data and project-related documents will be preserved during 15 year after the end of the study.
Statistical analysis Results for continuous variables will be summarized using mean ± (Standard Deviation) SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.
Sample size The sample size is calculated as a study of non-inferiority. Assuming a sensitivity for cancer of 85% for the 25S needle and a difference of sensitivity of 15% as clinically significant, a sample size of 112 patients per group would be needed (α = 0.05 and β = 0.2). Since we perform approximately 400 EUS-FNA biopsies for solid lesions annually,. it is expected that this study could be completed within approximately 6 months.
- Conditions
- Solid Lesion Biopsies
- Being tested
- 25g standard needle, 25d ProCor needle
- Keywords
- 25d ProCor needle, 22 gauge, endoscopic ultrasonography, fine needle biopsies, Patients, presenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25g standard needleDevice
Also called Evaluation of core samples, Cytological analysis, Ease of puncture
25d ProCor needleDevice
| Study group | Role | What they receive |
|---|---|---|
| 25g standard needle | Active comparator | EUS-FNA passes will be performed without stylet. One "needle pass" is defined as 5 strokes in 4 different areas of the lesion. The material from the needle passes will be expressed into formalin to look for core samples. Material from the next needle passes will be expressed onto slides for cytological analysis. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3). Receives: Device: 25g standard needle |
| 25d ProCor needle | Experimental | EUS-FNA passes will be performed without stylet. One "needle pass" is defined as 5 strokes in 4 different areas of the lesion. The material from the needle passes will be expressed into formalin to look for core samples. Material from the next needle passes will be expressed onto slides for cytological analysis. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3). Receives: Device: 25d ProCor needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the diagnostic yield of biopsies performed EUS-FNA by using the 25d ProCor needle versus the standard 25g needle
Measured: 1 day
Secondary outcomes (2)
Measurement of the size of the "core" samples produced by the two types of needles
Measured: 1 day
Measurement of incidence and severity of immediate complications associated with the two types of needles
Immediate complications will be assessed and recorded by nurses and/or physicians during and after the procedure while the patient was recovering from sedation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study start1 May 2014
- Primary completionJun 2018
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Solid Lesion BiopsiesStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand V Sahai, MD, Principal investigator, Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal) Montreal, Quebec, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048124
- Sponsor's protocol ID
- CE 13.030
- Status last verified
- May 2020
- First submitted
- 9 Jan 2014
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crowe DR, Eloubeidi MA, Chhieng DC, Jhala NC, Jhala D, Eltoum IA. Fine-needle aspiration biopsy of hepatic lesions: computerized tomographic-guided versus endoscopic ultrasound-guided FNA. Cancer. 2006 Jun 25;108(3):180-5. doi: 10.1002/cncr.21912.
PubMed 16634071Nguyen P, Feng JC, Chang KJ. Endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration (FNA) of liver lesions. Gastrointest Endosc. 1999 Sep;50(3):357-61. doi: 10.1053/ge.1999.v50.97208.
PubMed 10462656Jenssen C, Dietrich CF. Endoscopic ultrasound-guided fine-needle aspiration biopsy and trucut biopsy in gastroenterology - An overview. Best Pract Res Clin Gastroenterol. 2009;23(5):743-59. doi: 10.1016/j.bpg.2009.05.006.
PubMed 19744637Paquin SC, Gariepy G, Lepanto L, Bourdages R, Raymond G, Sahai AV. A first report of tumor seeding because of EUS-guided FNA of a pancreatic adenocarcinoma. Gastrointest Endosc. 2005 Apr;61(4):610-1. doi: 10.1016/s0016-5107(05)00082-9. No abstract available.
PubMed 15812422Eloubeidi MA, Chen VK, Eltoum IA, Jhala D, Chhieng DC, Jhala N, Vickers SM, Wilcox CM. Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications. Am J Gastroenterol. 2003 Dec;98(12):2663-8. doi: 10.1111/j.1572-0241.2003.08666.x.
PubMed 14687813Savides TJ, Donohue M, Hunt G, Al-Haddad M, Aslanian H, Ben-Menachem T, Chen VK, Coyle W, Deutsch J, DeWitt J, Dhawan M, Eckardt A, Eloubeidi M, Esker A, Gordon SR, Gress F, Ikenberry S, Joyce AM, Klapman J, Lo S, Maluf-Filho F, Nickl N, Singh V, Wills J, Behling C. EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement. Gastrointest Endosc. 2007 Aug;66(2):277-82. doi: 10.1016/j.gie.2007.01.017.
PubMed 17643700Williams DB, Sahai AV, Aabakken L, Penman ID, van Velse A, Webb J, Wilson M, Hoffman BJ, Hawes RH. Endoscopic ultrasound guided fine needle aspiration biopsy: a large single centre experience. Gut. 1999 May;44(5):720-6. doi: 10.1136/gut.44.5.720.
PubMed 10205212Wang KX, Ben QW, Jin ZD, Du YQ, Zou DW, Liao Z, Li ZS. Assessment of morbidity and mortality associated with EUS-guided FNA: a systematic review. Gastrointest Endosc. 2011 Feb;73(2):283-90. doi: 10.1016/j.gie.2010.10.045.
PubMed 21295642
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing the Diagnostic Yield of Solid Lesion Biopsies Performed by EUS-FNA Using the 25d ProCor Needle Versus the Standard 25g Needle.
- ClinicalTrials.gov ID
- NCT02048124
- Acronym / sponsor ID
- CE 13.030
- Conditions
- Solid Lesion Biopsies
- Keywords
- 25d ProCor needle, 22 gauge, endoscopic ultrasonography, fine needle biopsies, Patients, presenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 29 Jan 2014 (estimated)
- 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.
Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a new needle named "ProCor" was developed in the hope of obtaining core samples and thus increase diagnostic yield.
Objective: In this research project, we propose to conduct a prospective trial to compare the results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor needle (25gP).
EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P).
The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),[14] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive).
Results for continuous variables will be summarized using mean ± SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.
Detailed description
Objectives of the study
The primary objective is to compare the diagnostic yield of biopsies performed by EUS-FNA using the 25d ProCor needle versus the standard 25g needle.
The primary outcome is the diagnostic yield defined as: sensitivity for the presence of cancer based on the analysis of EUS-FNA samples.
The secondary objectives are:
- to compare the size of the "core" samples produced by the two types of needles.
- to compare the incidence and severity of immediate complications associated with the two types of needles
Methods
Design: This a prospective clinical study for the validation of a new instrument (ProCor biopsy needle) for application to clinical medicine, namely the diagnosis of cancer.
Endoscopic procedures:
Informed consent by the patient will be obtained before each procedure by a single research assistant.
All EUS examinations will be performed under conscious sedation (midazolam, fentanyl) by one two experienced endosonographers according to the standard procedures at the CHUM and using a linear echoendoscope. , If the lesion is considered solid and EUS-FNA is considered clinically indicated and safe, the patient will be enrolled and the randomisation envelope will be opened. EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P).
EUS-FNA passes will be performed without stylet. One "needle pass" is defined as 5 strokes in 4 different areas of the lesion. The material from the first 2 needle passes (one 25S and the other 25P) will be expressed into formalin to look for core samples. Material from the next 2 needle passes (again one 25S and the other 25P) will be expressed onto slides for cytological analysis. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3).
Immediate complications will be assessed and recorded by nurses and/or physicians during the procedure as well after the procedure while the patients will be monitored in the recovery room for at least 60 minutes before discharge.
The areas which will be investigated by biopsy will be the pancreas, the retroperitoneal and/or the mediastinal lymph nodes.
Cytological and Histological analyses:
Samples from all needle passes will be stained using a standard Papanicolaou stain and analyzed by one experienced pathologist who will be blinded as to needle type. The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),[14] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive).
Diagnostic yield Diagnostic yield is defined as sensitivity for the presence of cancer based on the analysis of EUS-FNA samples. The gold standard will be the presence of cancer as defined on the basis of at least one of the following two criteria: positive cytological or histological results and malignant disease after clinical follow up (clinical worsening and radiologic evidence of progression within the 6 months following FNA).
Data collection
Clinical data will be collected prospectively and saved in a database. In addition to demographics, these will include:
- size and location (pancreas, lymph node, liver, adrenal gland, others) of the target lesion
- technical and procedure variables ( FNA path, , number of needle passes, needle visibility, ease to puncture, needle failure, cellularity, bloodiness)
- cytological diagnosis
- final diagnosis
- immediate complications. Research data and project-related documents will be preserved during 15 year after the end of the study.
Statistical analysis Results for continuous variables will be summarized using mean ± (Standard Deviation) SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.
Sample size The sample size is calculated as a study of non-inferiority. Assuming a sensitivity for cancer of 85% for the 25S needle and a difference of sensitivity of 15% as clinically significant, a sample size of 112 patients per group would be needed (α = 0.05 and β = 0.2). Since we perform approximately 400 EUS-FNA biopsies for solid lesions annually,. it is expected that this study could be completed within approximately 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25g standard needle | Active comparator | Device: 25g standard needleEUS-FNA passes will be performed without stylet. One "needle pass" is defined as 5 strokes in 4 different areas of the lesion. The material from the needle passes will be expressed into formalin to look for core samples. Material from the next needle passes will be expressed onto slides for cytological analysis. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3). |
| 25d ProCor needle | Experimental | Device: 25d ProCor needleEUS-FNA passes will be performed without stylet. One "needle pass" is defined as 5 strokes in 4 different areas of the lesion. The material from the needle passes will be expressed into formalin to look for core samples. Material from the next needle passes will be expressed onto slides for cytological analysis. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: ≥ 18 years old
- Patients presenting with a solid lesion
- Patients for whom EUS-FNA is considered clinically indicated and safe
Key exclusion criteria (3 listed)
- Age < 18 years old,
- Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis or other lesions in which a large amount of tissue will be required for diagnosis,
- Patients with significant coagulopathy (INR>1.5, platelets <50000/mm3, use of low molecular weight heparin, use of clopidogrel within 7 days of EUS), Patients presenting with cystic lesions Inability or refusal to sign the 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 |
|---|---|---|
| 25g standard needleAlso: Evaluation of core samples, Cytological analysis, Ease of puncture | Device | 25g standard needle |
| 25d ProCor needle | Device | 25d ProCor needle |
Primary outcome
Compare the diagnostic yield of biopsies performed EUS-FNA by using the 25d ProCor needle versus the standard 25g needle
Time frame: 1 day
2 secondary outcomes
Measurement of the size of the "core" samples produced by the two types of needles
Time frame: 1 day
Measurement of incidence and severity of immediate complications associated with the two types of needles
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 16634071Crowe DR, Eloubeidi MA, Chhieng DC, Jhala NC, Jhala D, Eltoum IA. Fine-needle aspiration biopsy of hepatic lesions: computerized tomographic-guided versus endoscopic ultrasound-guided FNA. Cancer. 2006 Jun 25;108(3):180-5. doi: 10.1002/cncr.21912.
- Background: PubMed 10462656Nguyen P, Feng JC, Chang KJ. Endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration (FNA) of liver lesions. Gastrointest Endosc. 1999 Sep;50(3):357-61. doi: 10.1053/ge.1999.v50.97208.
- Background: PubMed 19744637Jenssen C, Dietrich CF. Endoscopic ultrasound-guided fine-needle aspiration biopsy and trucut biopsy in gastroenterology - An overview. Best Pract Res Clin Gastroenterol. 2009;23(5):743-59. doi: 10.1016/j.bpg.2009.05.006.
- Background: PubMed 15812422Paquin SC, Gariepy G, Lepanto L, Bourdages R, Raymond G, Sahai AV. A first report of tumor seeding because of EUS-guided FNA of a pancreatic adenocarcinoma. Gastrointest Endosc. 2005 Apr;61(4):610-1. doi: 10.1016/s0016-5107(05)00082-9. No abstract available.
- Background: PubMed 14687813Eloubeidi MA, Chen VK, Eltoum IA, Jhala D, Chhieng DC, Jhala N, Vickers SM, Wilcox CM. Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications. Am J Gastroenterol. 2003 Dec;98(12):2663-8. doi: 10.1111/j.1572-0241.2003.08666.x.
- Background: PubMed 17643700Savides TJ, Donohue M, Hunt G, Al-Haddad M, Aslanian H, Ben-Menachem T, Chen VK, Coyle W, Deutsch J, DeWitt J, Dhawan M, Eckardt A, Eloubeidi M, Esker A, Gordon SR, Gress F, Ikenberry S, Joyce AM, Klapman J, Lo S, Maluf-Filho F, Nickl N, Singh V, Wills J, Behling C. EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement. Gastrointest Endosc. 2007 Aug;66(2):277-82. doi: 10.1016/j.gie.2007.01.017.
- Background: PubMed 10205212Williams DB, Sahai AV, Aabakken L, Penman ID, van Velse A, Webb J, Wilson M, Hoffman BJ, Hawes RH. Endoscopic ultrasound guided fine needle aspiration biopsy: a large single centre experience. Gut. 1999 May;44(5):720-6. doi: 10.1136/gut.44.5.720.
- Background: PubMed 21295642Wang KX, Ben QW, Jin ZD, Du YQ, Zou DW, Liao Z, Li ZS. Assessment of morbidity and mortality associated with EUS-guided FNA: a systematic review. Gastrointest Endosc. 2011 Feb;73(2):283-90. doi: 10.1016/j.gie.2010.10.045.
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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.
Anand V Sahai, MD principal investigator
Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal) Montreal, Quebec, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25g standard needle and 25d ProCor needle in people with Solid Lesion Biopsies, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 10 Nov 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the diagnostic yield of biopsies performed EUS-FNA by using the 25d ProCor needle versus the standard 25g needle (time frame: 1 day). 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 NCT02048124, which also lists 8 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 10 Nov 2020.