Solid Pancreatic TumorNCT03435588
Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions
A study testing EUS, FNA with ROSE and FNB alone in people with Solid Pancreatic Tumor, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 6 sites in Canada.
Trial summary
Currently, the best way to evaluate pancreatic masses is through endoscopic-guided needle sampling of the mass to determine the diagnosis by looking at the acquired tissue under a microscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Pancreatic Tumor
- What is being tested?
- EUS, FNA with ROSE and FNB alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 6 sitesCanada
- Study dates
- 14 Feb 2018to 15 Dec 2019
- 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
- Patients referred for EUS evaluation of a definite solid pancreatic mass noted on computed tomography(CT)/Magnetic resonance imaging(MRI)/EUS, in which malignancy is suspected with no previous histological diagnosis
Who cannot join
- Age < 18 years, pregnant patients.
- Uncorrectable coagulopathy Prothrombin time (PT) >50% of control, Partial Thromboplastin time (PTT) >50 sec, or International normalized ratio (INR) >1.5 and/or uncorrectable thrombocytopenia platelet count<50, 000109/L.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Alberta
Edmonton, Alberta
Moncton Hospital
Moncton, New Brunswick
Jewish General Hospital
Montreal, Quebec, H2V 2Y4
McGill University Health Centre
Montreal, Quebec, H3G 1A4
The Ottawa Hospital
Ottawa, Ontario
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions: a Randomized Controlled Trial
Currently, the best way to evaluate pancreatic masses is through endoscopic-guided needle sampling of the mass to determine the diagnosis by looking at the acquired tissue under a microscope. This is done by inserting a small camera (endoscope) through the mouth of the patient then advanced to the stomach and using ultrasound guidance a sample of the pancreas can be acquired through the stomach. The sampling is usually done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed immediately under the microscope and can give feedback to the endoscopist until enough cells has been acquired for a diagnosis. This method has been shown to increase the ability to diagnose pancreatic cancer but is expensive and requires significant amount of resources. New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology) and has been shown to be also very accurate in the diagnosis of pancreatic cancer.
The purpose of this study is to compare endoscopy-guided biopsy of pancreatic masses with the new core needle (FNB), which can obtain more tissue for diagnosis vs. using a traditional needle (FNA) with the help of an immediate assessment of the obtained samples under the microscope to determine whether enough tissue has been obtained (ROSE). Both approaches have been shown to increase the accuracy of diagnosis in solid pancreatic masses but it is unclear which one is superior. This is a randomized trial meaning that the participants would either undergo biopsy with the new needle or with the traditional needle plus the addition of on-site assessment of the obtained samples. The advantage of the new needle is that it is easy to implement and likely much cheaper. If the investigators can show in our study that the new needles are as accurate as FNA with ROSE then FNB could be implemented across hospitals worldwide in an easier and less expensive fashion.
- Conditions
- Solid Pancreatic Tumor
- Being tested
- EUS, FNA with ROSE, FNB alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUSProcedure or surgery
Radial endoscopic ultrasound. A special endoscope uses high-frequency sound waves to produce detailed images of the lining and walls of the digestive tract , and allows to take samples from abnormal areas.
FNA with ROSEProcedure or surgery
Endoscopic ultrasound guided biopsy of the pancreas with the traditional fine needle aspirate needle with the addition of rapid on-site cytopathology (cytopathologist looking at each biopsy samples as they are taken): The sampling is done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed.
FNB aloneProcedure or surgery
Endoscopic ultrasound guided biopsy with a novel core biopsy needle without on-site cytopathology: New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology).
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA with ROSE | Active comparator | EUS-FNA with ROSE is performed with a 22 or 25 gauge FNA needle. The sampled specimen is expressed into a glass slide with a stylet; then using another glass slide the sample is spread out to make smears on two slides. Each pair of slides is then numbered according to their respective needle passes. One slide is air dried and stained with modified Giemsa stain for ROSE, while the other slide is fixed in 95% ethanol and later coated with with Papanicolaou stain. Receives: Procedure: EUS; Procedure: FNA with ROSE |
| EUS-FNB alone | Experimental | EUS-FNB is performed with a 22 or 25 gauge Core-needle. Tissue sampling technique is standardized between the endoscopists. Two passes are performed using the core needle. The biopsied samples are then expressed using a stylet into a jar filled with 10% formalin. A third pass is allowed if, on macroscopic inspection of the acquired sample, the specimen is deemed insufficient by the endoscopist. Receives: Procedure: EUS; Procedure: FNB alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Defined as (true positive + true negative)/all samples
Measured: 12 months
Final diagnosis of malignant pancreatic mass
Will be based on the following criteria:
- Histological evidence of malignancy on the corresponding subsequent surgical specimen
- Presence of an unresectable lesion during subsequent surgery
- Malignant cytology/pathology on EUS-sampling followed by documented loco-regional progression/development of metastases on follow-up axial imaging.
Measured: 10 months
Final diagnosis of benign pancreatic mass
Will be based on the following criteria:
- Surgical pathology or exploration showing the absence of malignancy
- Follow-up imaging at > 6 months reporting stability of the pancreatic lesion
- Cytological or histopathological diagnosis of benign disease with an appropriate clinical course of disease for minimum of 6 months
Measured: 10 months
Secondary outcomes (5)
Diagnostic characteristics
sensitivity, specificity, positive and negative predictive value
Measured: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Specimen adequacy
Defined as the proportion of samples in which a final histopathological diagnosis could be made
Measured: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Median number of needle passes
Number of times passing the needle for tissue acquisition
Measured: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Procedural time
Time spent during the procedure
Measured: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Rate of procedure-related adverse events
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a procedure done, whether or not considered causally related to the procedure.
A serious adverse event is an adverse event occurring during the procedure or any time after the procedure, that fulfills one or more of the following criteria:
- Results in death
- Is immediately life-threatening
- Requires in-patient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability or incapacity
- Is a congenital abnormality or birth defect
- Is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above.
Measured: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start14 Feb 2018
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Solid Pancreatic TumorStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Parallel groups
- Model description
- Procedures are performed with a linear echoendoscope under conscious sedation. EUS-FNB is performed with a 22G or 25G needles Core-needle. Tissue sampling technique is standardized between the endoscopists. Two passes are performed using the core needle. A third pass is allowed if, on macroscopic inspection of the acquired sample, the specimen is deemed insufficient by the endoscopist. EUS-FNA with ROSE is performed with a 22 or 25 gauge FNA needle. This is a multi-center, randomized, single blinded, non-inferiority, trial comparing EUS-FNB alone to EUS-FNA with ROSE in the diagnosis of solid pancreatic masses. Following consent, patients are randomized, at the time of the procedure, to undergo either EUS-FNB alone or EUS-FNA with ROSE. The randomization sequence will be generated by a computerized randomization scheme using a block size of 10 stratified according to the endoscopist.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-I Chen, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Yen-I Chen, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435588
- Sponsor's protocol ID
- 22125
- Status last verified
- Dec 2020
- First submitted
- 15 Jan 2018
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klapman JB, Logrono R, Dye CE, Waxman I. Clinical impact of on-site cytopathology interpretation on endoscopic ultrasound-guided fine needle aspiration. Am J Gastroenterol. 2003 Jun;98(6):1289-94. doi: 10.1111/j.1572-0241.2003.07472.x.
PubMed 12818271Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.
PubMed 9087830Chang KJ, Katz KD, Durbin TE, Erickson RA, Butler JA, Lin F, Wuerker RB. Endoscopic ultrasound-guided fine-needle aspiration. Gastrointest Endosc. 1994 Nov-Dec;40(6):694-9.
PubMed 7859967Kulesza P, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration: sampling, pitfalls, and quality management. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1248-54. doi: 10.1016/j.cgh.2007.09.011.
PubMed 17981244Kandel P, Tranesh G, Nassar A, Bingham R, Raimondo M, Woodward TA, Gomez V, Wallace MB. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc. 2016 Dec;84(6):1034-1039. doi: 10.1016/j.gie.2016.03.1405. Epub 2016 Mar 24.
PubMed 27018087Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503Chen YI, Chatterjee A, Berger R, Kanber Y, Wyse J, Lam E, Gan I, Auger M, Kenshil S, Telford J, Donnellan F, Quinlan J, Lutzak G, Alshamsi F, Parent J, Waschke K, Alghamdi A, Barkun J, Metrakos P, Chaudhury P, Martel M, Dorreen A, Candido K, Miller C, Adam V, Barkun A, Zogopoulos G, Wong C. Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial. Endoscopy. 2022 Jan;54(1):4-12. doi: 10.1055/a-1375-9775. Epub 2021 Apr 15.
PubMed 33506455
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03435588
- Acronym / sponsor ID
- 22125
- Conditions
- Solid Pancreatic Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 19 Feb 2018 (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.
Currently, the best way to evaluate pancreatic masses is through endoscopic-guided needle sampling of the mass to determine the diagnosis by looking at the acquired tissue under a microscope. This is done by inserting a small camera (endoscope) through the mouth of the patient then advanced to the stomach and using ultrasound guidance a sample of the pancreas can be acquired through the stomach. The sampling is usually done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed immediately under the microscope and can give feedback to the endoscopist until enough cells has been acquired for a diagnosis. This method has been shown to increase the ability to diagnose pancreatic cancer but is expensive and requires significant amount of resources. New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology) and has been shown to be also very accurate in the diagnosis of pancreatic cancer.
The purpose of this study is to compare endoscopy-guided biopsy of pancreatic masses with the new core needle (FNB), which can obtain more tissue for diagnosis vs. using a traditional needle (FNA) with the help of an immediate assessment of the obtained samples under the microscope to determine whether enough tissue has been obtained (ROSE). Both approaches have been shown to increase the accuracy of diagnosis in solid pancreatic masses but it is unclear which one is superior. This is a randomized trial meaning that the participants would either undergo biopsy with the new needle or with the traditional needle plus the addition of on-site assessment of the obtained samples. The advantage of the new needle is that it is easy to implement and likely much cheaper. If the investigators can show in our study that the new needles are as accurate as FNA with ROSE then FNB could be implemented across hospitals worldwide in an easier and less expensive fashion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Procedures are performed with a linear echoendoscope under conscious sedation. EUS-FNB is performed with a 22G or 25G needles Core-needle. Tissue sampling technique is standardized between the endoscopists. Two passes are performed using the core needle. A third pass is allowed if, on macroscopic inspection of the acquired sample, the specimen is deemed insufficient by the endoscopist. EUS-FNA with ROSE is performed with a 22 or 25 gauge FNA needle. This is a multi-center, randomized, single blinded, non-inferiority, trial comparing EUS-FNB alone to EUS-FNA with ROSE in the diagnosis of solid pancreatic masses. Following consent, patients are randomized, at the time of the procedure, to undergo either EUS-FNB alone or EUS-FNA with ROSE. The randomization sequence will be generated by a computerized randomization scheme using a block size of 10 stratified according to the endoscopist.
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA with ROSE | Active comparator | Procedure: EUS, Procedure: FNA with ROSEEUS-FNA with ROSE is performed with a 22 or 25 gauge FNA needle. The sampled specimen is expressed into a glass slide with a stylet; then using another glass slide the sample is spread out to make smears on two slides. Each pair of slides is then numbered according to their respective needle passes. One slide is air dried and stained with modified Giemsa stain for ROSE, while the other slide is fixed in 95% ethanol and later coated with with Papanicolaou stain. |
| EUS-FNB alone | Experimental | Procedure: EUS, Procedure: FNB aloneEUS-FNB is performed with a 22 or 25 gauge Core-needle. Tissue sampling technique is standardized between the endoscopists. Two passes are performed using the core needle. The biopsied samples are then expressed using a stylet into a jar filled with 10% formalin. A third pass is allowed if, on macroscopic inspection of the acquired sample, the specimen is deemed insufficient by the endoscopist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Patients referred for EUS evaluation of a definite solid pancreatic mass noted on computed tomography(CT)/Magnetic resonance imaging(MRI)/EUS, in which malignancy is suspected with no previous histological diagnosis
Key exclusion criteria (2 listed)
- Age < 18 years, pregnant patients.
- Uncorrectable coagulopathy Prothrombin time (PT) >50% of control, Partial Thromboplastin time (PTT) >50 sec, or International normalized ratio (INR) >1.5 and/or uncorrectable thrombocytopenia platelet count<50, 000109/L.
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 |
|---|---|---|
| EUSRadial endoscopic ultrasound. A special endoscope uses high-frequency sound waves to produce detailed images of the lining and walls of the digestive tract , and allows to take samples from abnormal areas. | Procedure or surgery | EUS-FNA with ROSE, EUS-FNB alone |
| FNA with ROSEEndoscopic ultrasound guided biopsy of the pancreas with the traditional fine needle aspirate needle with the addition of rapid on-site cytopathology (cytopathologist looking at each biopsy samples as they are taken): The sampling is done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed. | Procedure or surgery | EUS-FNA with ROSE |
| FNB aloneEndoscopic ultrasound guided biopsy with a novel core biopsy needle without on-site cytopathology: New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology). | Procedure or surgery | EUS-FNB alone |
Primary outcome
Diagnostic accuracy
Time frame: 12 months
Defined as (true positive + true negative)/all samples
Final diagnosis of malignant pancreatic mass
Time frame: 10 months
Will be based on the following criteria: * Histological evidence of malignancy on the corresponding subsequent surgical specimen * Presence of an unresectable lesion during subsequent surgery * Malignant cytology/pathology on EUS-sampling followed by documented loco-regional progression/development of metastases on follow-up axial imaging.
Final diagnosis of benign pancreatic mass
Time frame: 10 months
Will be based on the following criteria: * Surgical pathology or exploration showing the absence of malignancy * Follow-up imaging at > 6 months reporting stability of the pancreatic lesion * Cytological or histopathological diagnosis of benign disease with an appropriate clinical course of disease for minimum of 6 months
5 secondary outcomes
Diagnostic characteristics
Time frame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Specimen adequacy
Time frame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Median number of needle passes
Time frame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Procedural time
Time frame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Rate of procedure-related adverse events
Time frame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
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 11 Dec 2020.
- Background: PubMed 12818271Klapman JB, Logrono R, Dye CE, Waxman I. Clinical impact of on-site cytopathology interpretation on endoscopic ultrasound-guided fine needle aspiration. Am J Gastroenterol. 2003 Jun;98(6):1289-94. doi: 10.1111/j.1572-0241.2003.07472.x.
- Background: PubMed 9087830Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.
- Background: PubMed 7859967Chang KJ, Katz KD, Durbin TE, Erickson RA, Butler JA, Lin F, Wuerker RB. Endoscopic ultrasound-guided fine-needle aspiration. Gastrointest Endosc. 1994 Nov-Dec;40(6):694-9.
- Background: PubMed 17981244Kulesza P, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration: sampling, pitfalls, and quality management. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1248-54. doi: 10.1016/j.cgh.2007.09.011.
- Background: PubMed 27018087Kandel P, Tranesh G, Nassar A, Bingham R, Raimondo M, Woodward TA, Gomez V, Wallace MB. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc. 2016 Dec;84(6):1034-1039. doi: 10.1016/j.gie.2016.03.1405. Epub 2016 Mar 24.
- Background: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Derived from this study: PubMed 33506455Chen YI, Chatterjee A, Berger R, Kanber Y, Wyse J, Lam E, Gan I, Auger M, Kenshil S, Telford J, Donnellan F, Quinlan J, Lutzak G, Alshamsi F, Parent J, Waschke K, Alghamdi A, Barkun J, Metrakos P, Chaudhury P, Martel M, Dorreen A, Candido K, Miller C, Adam V, Barkun A, Zogopoulos G, Wong C. Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial. Endoscopy. 2022 Jan;54(1):4-12. doi: 10.1055/a-1375-9775. Epub 2021 Apr 15.
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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.
Yen-I Chen, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS, FNA with ROSE and FNB alone in people with Solid Pancreatic Tumor, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 6 sites 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 2 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: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Diagnostic accuracy (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT03435588, which also lists 7 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 11 Dec 2020.