Pancreatic NeoplasmsSINSNCT02424838
22 G - 25 G SINS Trial for Pancreatic Masses
A study testing EUS-FNA of pancreatic masses, 22 gauge needle and 25 gauge needle in people with Pancreatic Neoplasms, run by AdventHealth at 1 site in United States.
Trial summary
After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups: 22 gauge (G) needle with suction 25 G needle with suction 22 G needle without… Read more about this study
- Who is it for?
- Ages 19 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- EUS-FNA of pancreatic masses, 22 gauge needle and 25 gauge needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2014to 30 Sep 2018
- 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 19 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA
- Age ≥ 19 years
Who cannot join
- Age <19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
- Unable to provide consent for any reason
- Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Examining the Relationship Between Procedural Technique and Specimen Evaluation Methods in Patients Undergoing Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) of Pancreatic Masses
After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups:
- 22 gauge (G) needle with suction
- 25 G needle with suction
- 22 G needle without suction
- 25 G needle without suction
Follow-up Phone Call Phase:
Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.
Read the detailed description
All adult patients referred to Florida Hospital for evaluation of a pancreatic mass lesion will be eligible for entry into the study. Patients will be approached at the time of procedural consent for the study.
- After written informed consent is taken, Endoscopic Ultrasound (EUS) will be performed under conscious sedation.
- At the time of EUS, patients who require FNA will be randomized to the two needles (22 G or 25 G needles) and to the two techniques (using suction or not using suction).
- Computer-generated randomization assignments using the block randomization method will be obtained from the statistician prior to study enrollment. These will be placed in sequentially numbered sealed opaque envelopes and opened by the endoscopy nurse immediately after the decision to perform FNA is made. The randomization sequence will specify the needle size to be used and whether or not suction will be applied for FNA.
- FNA will be performed in the standard fashion using one of the designated needle sizes (using the fanning technique to pass the needle 12-16 times into the lesion) by one of the experienced endosonographers in the unit. The needle stylet will be left in place for the first pass and then removed for subsequent passes. Suction will be applied during aspiration of the mass as dictated by the randomization sequence.
- First two passes will be performed to obtain tissue sample for cell block analysis. Therefore, the tissue obtained with the first and second passes will be expressed onto a slide and into test tubes for cell block analysis.
- From the third pass onwards, the aspirate obtained will be examined onsite by the cytopathologist, who will be available to interpret the slides immediately to determine diagnostic adequacy of the sample per standard practice. Once the diagnosis is made and the adequacy of the sample is affirmed by the cytopathologist, the procedure will be stopped and the echoendoscope will be withdrawn from the patient.
- Total number of passes to obtain a diagnostic cytological aspirate made will be recorded at the time of procedure, as well as the occurrence of needle dysfunction, technical failure, and any immediate complications.
- The samples taken will be transported to the pathology lab (per standard practice) where the cellular aspirate and cell block samples will be evaluated by the pathologist. 10% of samples from each subgroup (i.e. 22G with suction, 22G without suction, 25G with suction, 25G without suction) will be further analyzed for the presence of molecular markers for malignancy.
- After the appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.
- Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.
- Conditions
- Pancreatic Neoplasms
- Being tested
- EUS-FNA of pancreatic masses, 22 gauge needle, 25 gauge needle
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNA of pancreatic massesProcedure or surgery
EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.
22 gauge needleDevice
25 gauge needleDevice
| Study group | Role | What they receive |
|---|---|---|
| 22 gauge with suction | Active comparator | EUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction. Receives: Procedure: EUS-FNA of pancreatic masses; Device: 22 gauge needle |
| 22 gauge without suction | Active comparator | EUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction. Receives: Procedure: EUS-FNA of pancreatic masses; Device: 22 gauge needle |
| 25 gauge with suction | Active comparator | EUS-FNA of pancreatic masses will be performed with a 25 gauge needle using suction. Receives: Procedure: EUS-FNA of pancreatic masses; Device: 25 gauge needle |
| 25 gauge without suction | Active comparator | EUS-FNA of pancreatic masses will be performed with a 25 gauge needle without suction. Receives: Procedure: EUS-FNA of pancreatic masses; Device: 25 gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of diagnostic cell block specimens obtained according to needle size and the use of suction.
The use of suction and a larger gauge needle during EUS-FNA is likely to increase the diagnostic yield of cell block. This may in turn translate to improved diagnosis and hence expedite patient management
Measured: 7 days (cell block processing in lab)
Secondary outcomes (5)
Diagnostic adequacy of FNA cytology
- Diagnostic adequacy of FNA cytology samples and comparison between the two needle sizes and the effect of application of suction
Measured: 24 hours
Median number of passes to diagnosis
- Median no. of passes required to obtain diagnostically adequate cytological samples, and comparison between the two needle sizes and suction vs. no suction
Measured: 24 hours
Specimen bloodiness
- Specimen bloodiness and comparison between the two needle sizes and two techniques (with and without suction)
Measured: 24 hours
Rate of needle dysfunction
- Rate of needle dysfunction and technical failure, and comparison between the two needle sizes and two techniques (with and without suction)
Measured: 24 hours
Rate of complications
- Rate of complications following EUS-FNA, and comparison between the two needle sizes and two techniques (with and without suction)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study start28 Jul 2014
- Primary completion3 Apr 2016
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam S Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424838
- Sponsor's protocol ID
- 618366
- Acronym
- SINS
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share Individual Participant Data.
Publications
Bang JY, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Endoscopic Ultrasound-guided Specimen Collection and Evaluation Techniques Affect Diagnostic Accuracy. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1820-1828.e4. doi: 10.1016/j.cgh.2018.03.004. Epub 2018 Mar 11.
PubMed 29535060
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Examining the Relationship Between Procedural Technique and Specimen Evaluation Methods in Patients Undergoing Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) of Pancreatic Masses
- ClinicalTrials.gov ID
- NCT02424838
- Acronym / sponsor ID
- SINS / 618366
- Conditions
- Pancreatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 28 Jul 2014 (actual)
- Primary completion
- 3 Apr 2016 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 23 Apr 2015 (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.
After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups:
- 22 gauge (G) needle with suction
- 25 G needle with suction
- 22 G needle without suction
- 25 G needle without suction
Follow-up Phone Call Phase:
Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.
Detailed description
All adult patients referred to Florida Hospital for evaluation of a pancreatic mass lesion will be eligible for entry into the study. Patients will be approached at the time of procedural consent for the study.
- After written informed consent is taken, Endoscopic Ultrasound (EUS) will be performed under conscious sedation.
- At the time of EUS, patients who require FNA will be randomized to the two needles (22 G or 25 G needles) and to the two techniques (using suction or not using suction).
- Computer-generated randomization assignments using the block randomization method will be obtained from the statistician prior to study enrollment. These will be placed in sequentially numbered sealed opaque envelopes and opened by the endoscopy nurse immediately after the decision to perform FNA is made. The randomization sequence will specify the needle size to be used and whether or not suction will be applied for FNA.
- FNA will be performed in the standard fashion using one of the designated needle sizes (using the fanning technique to pass the needle 12-16 times into the lesion) by one of the experienced endosonographers in the unit. The needle stylet will be left in place for the first pass and then removed for subsequent passes. Suction will be applied during aspiration of the mass as dictated by the randomization sequence.
- First two passes will be performed to obtain tissue sample for cell block analysis. Therefore, the tissue obtained with the first and second passes will be expressed onto a slide and into test tubes for cell block analysis.
- From the third pass onwards, the aspirate obtained will be examined onsite by the cytopathologist, who will be available to interpret the slides immediately to determine diagnostic adequacy of the sample per standard practice. Once the diagnosis is made and the adequacy of the sample is affirmed by the cytopathologist, the procedure will be stopped and the echoendoscope will be withdrawn from the patient.
- Total number of passes to obtain a diagnostic cytological aspirate made will be recorded at the time of procedure, as well as the occurrence of needle dysfunction, technical failure, and any immediate complications.
- The samples taken will be transported to the pathology lab (per standard practice) where the cellular aspirate and cell block samples will be evaluated by the pathologist. 10% of samples from each subgroup (i.e. 22G with suction, 22G without suction, 25G with suction, 25G without suction) will be further analyzed for the presence of molecular markers for malignancy.
- After the appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.
- Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 22 gauge with suction | Active comparator | Procedure: EUS-FNA of pancreatic masses, Device: 22 gauge needleEUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction. |
| 22 gauge without suction | Active comparator | Procedure: EUS-FNA of pancreatic masses, Device: 22 gauge needleEUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction. |
| 25 gauge with suction | Active comparator | Procedure: EUS-FNA of pancreatic masses, Device: 25 gauge needleEUS-FNA of pancreatic masses will be performed with a 25 gauge needle using suction. |
| 25 gauge without suction | Active comparator | Procedure: EUS-FNA of pancreatic masses, Device: 25 gauge needleEUS-FNA of pancreatic masses will be performed with a 25 gauge needle without suction. |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA
- Age ≥ 19 years
Key exclusion criteria (5 listed)
- Age <19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
- Unable to provide consent for any reason
- Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)
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 |
|---|---|---|
| EUS-FNA of pancreatic massesEUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction. | Procedure or surgery | 22 gauge with suction, 22 gauge without suction, 25 gauge with suction, 25 gauge without suction |
| 22 gauge needle | Device | 22 gauge with suction, 22 gauge without suction |
| 25 gauge needle | Device | 25 gauge with suction, 25 gauge without suction |
Primary outcome
Proportion of diagnostic cell block specimens obtained according to needle size and the use of suction.
Time frame: 7 days (cell block processing in lab)
The use of suction and a larger gauge needle during EUS-FNA is likely to increase the diagnostic yield of cell block. This may in turn translate to improved diagnosis and hence expedite patient management
5 secondary outcomes
Diagnostic adequacy of FNA cytology
Time frame: 24 hours
Median number of passes to diagnosis
Time frame: 24 hours
Specimen bloodiness
Time frame: 24 hours
Rate of needle dysfunction
Time frame: 24 hours
Rate of complications
Time frame: 3 days
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 15 Feb 2019.
- Derived from this study: PubMed 29535060Bang JY, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Endoscopic Ultrasound-guided Specimen Collection and Evaluation Techniques Affect Diagnostic Accuracy. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1820-1828.e4. doi: 10.1016/j.cgh.2018.03.004. Epub 2018 Mar 11.
- Individual participant dataSharing planned: No. There is no plan to share Individual Participant Data.
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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.
Shyam S 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 EUS-FNA of pancreatic masses, 22 gauge needle and 25 gauge needle 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 2 inclusion and 5 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 15 Feb 2019. 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?
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?
Proportion of diagnostic cell block specimens obtained according to needle size and the use of suction. (time frame: 7 days (cell block processing in lab)). 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 NCT02424838, which also lists 1 linked publication.
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 15 Feb 2019.