Pancreatic Solid LesionsPhase 3NCT01936467

Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions

A Phase 3 study testing Standard technique EUS-FNA and Capillary suction technique for EUS FNA in people with Pancreatic Solid Lesions and Pancreatic Mass, run by Johns Hopkins University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Pancreatic Solid Lesions, Pancreatic Mass
What is being tested?: Standard technique EUS-FNA and Capillary suction technique for EUS FNA
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 2 sitesUnited States
Study dates: Jan 2013to Jan 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA

Who cannot join

Uncorrectable coagulopathy (INR > 1.5)
Uncorrectable thrombocytopenia (platelet < 50,000)
Uncooperative patients
Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
Refusal to consent form
Cystic lesions
Inaccessible lesions to EUS

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Howard County General Hospital
Columbia, Maryland, 21044

Other trials in United States

About this study

Official title: Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided

The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.

There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.

Conditions: Pancreatic Solid Lesions, Pancreatic Mass
Being tested: Standard technique EUS-FNA, Capillary suction technique for EUS FNA
Keywords: Pancreatic solid lesions, Pancreatic mass, Pancreatic cancer, Endoscopic Ultrasound, EUS, Fine needle aspiration, FNA, EUS-FNA
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard technique EUS-FNADevice
Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Capillary suction technique for EUS FNADevice
Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Study groups in NCT01936467
Study group	Role	What they receive
Standard suction	Experimental	These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Receives: Device: Standard technique EUS-FNA
Capillary suction	Experimental	These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously. Receives: Device: Capillary suction technique for EUS FNA

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Yield of Capillary Technique
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Measured: up to 6 months
Diagnostic Yield of Standard Technique
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Measured: up to 6 months
Sensitivity of EUS-FNA With Capillary Technique
Sensitivity of the EUS-FNA with Capillary technique
Measured: 6 months
Sensitivity of EUS-FNA With StandardTechnique
Sensitivity of the EUS-FNA with Capillary technique
Measured: 6 months
Sensitivity of EUS-FNA
Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions
Measured: 6 months

Secondary outcomes (3)

First Pass Diagnostic Rate
The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass
Measured: immediate
Acquisition of Core Tissue
The rate of acquiring core tissue of the pancreatic mass through EUS-FNA
Measured: immediate
Diagnostic Accuracy of EUS-FNA
The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jan 2015

First posted6 Sep 2013 (estimated)
Study startJan 2013
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pancreatic Solid LesionsStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe 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 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01936467
Sponsor's protocol ID: NA_00079301
Status last verified: Mar 2017
First submitted: 29 Aug 2013
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.
PubMed 29272906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) Malignancy
Pancreas Adenocarcinoma (MSI-H), Pancreatic Neuroendocrine Tumors (pNET)
Not yet recruitingObservational study
EUS-DFI in Solid Pancreatic Lesions
Pancreatic Neoplasms, Pancreatic Solid Lesions
RecruitingObservational study
An Artificial Intelligence System for Multimodal, Multi-class Diagnosing Solid Pancreatic Lesions Based on Endoscopic Ultrasound
Endoscopic Ultrasound (EUS), Solid Pancreatic Lesion
Not yet recruiting
22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions
Pancreatic Neoplasms, Mediastinal Neoplasms
Recruiting
RCT Comparing Accuracy Among Franseen, Forward-bevel Westcott, and Fork-tip EUS-FNB Needle in Diagnosis of Solid Pancreatic Lesions
Pancreatic Masses

All Pancreatic Solid Lesions trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided
ClinicalTrials.gov ID: NCT01936467
Acronym / sponsor ID: NA_00079301
Conditions: Pancreatic Solid Lesions, Pancreatic Mass
Keywords: Pancreatic solid lesions, Pancreatic mass, Pancreatic cancer, Endoscopic Ultrasound, EUS, Fine needle aspiration, FNA, EUS-FNA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Boston Scientific Corporation
Study start: Jan 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 6 Sep 2013 (estimated)
Results: Posted 13 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard suction	Experimental	Device: Standard technique EUS-FNAThese are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Capillary suction	Experimental	Device: Capillary suction technique for EUS FNAThese are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA

Key exclusion criteria (7 listed)

Uncorrectable coagulopathy (INR > 1.5)
Uncorrectable thrombocytopenia (platelet < 50,000)
Uncooperative patients
Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
Refusal to consent form

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
Standard technique EUS-FNAStandard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.	Device	Standard suction
Capillary suction technique for EUS FNACapillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously	Device	Capillary suction

Primary outcome

Diagnostic Yield of Capillary Technique
Time frame: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Diagnostic Yield of Standard Technique
Time frame: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Sensitivity of EUS-FNA With Capillary Technique
Time frame: 6 months
Sensitivity of the EUS-FNA with Capillary technique
Sensitivity of EUS-FNA With StandardTechnique
Time frame: 6 months
Sensitivity of the EUS-FNA with Capillary technique
Sensitivity of EUS-FNA
Time frame: 6 months
Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions

3 secondary outcomes

First Pass Diagnostic Rate
Time frame: immediate
Acquisition of Core Tissue
Time frame: immediate
Diagnostic Accuracy of EUS-FNA
Time frame: 6 months

Results and safety

Results posted to the registry on 13 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suction Technique	60	60
Capillary Technique	61	61

Primary outcome: Diagnostic Yield of Capillary Technique

Time frame: up to 6 months. Number. Unit: percentage of specimen

Measure	Capillary Technique n = 61
Value	75.4

Primary outcome: Diagnostic Yield of Standard Technique

Time frame: up to 6 months. Number. Unit: percentage of specimen

Measure	Standard Technique n = 60
Value	65

Primary outcome: Sensitivity of EUS-FNA With Capillary Technique

Time frame: 6 months. Number. Unit: participants

Measure	Patients With Positive Gold Standard n = 48	Patients With Negative Gold Standard n = 4
Positive EUS-FNA	45	0
Negative EUS-FNA	3	4

Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Sensitivity: 93.7
Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Specificity: 100

Population analysed: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.

Primary outcome: Sensitivity of EUS-FNA With StandardTechnique

Time frame: 6 months. Number. Unit: Participants

Measure	Patients With Positive Gold Standard n = 44	Patients With Negative Gold Standard n = 0
Positive EUS-FNA	39	–
Negative EUS-FNA	5	–

Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Sensitivity: 88.6
Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Specificity: 100

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suction Technique	0 of 60 (0%)	0 of 60 (0%)	Not reported
Capillary Technique	0 of 61 (0%)	0 of 61 (0%)	Not reported

Limitations and caveats (from the sponsor): The endosonographers were not blinded to the procedure technique. A small possibility that cytotechnicians may have witnessed the technique. Cellularity of the specimens were not quantified. A 6 months follow-up may not detect all false negatives

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29272906Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.

Related trials for Pancreatic Solid Lesions

Recruiting
Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) Malignancy
Pancreas Adenocarcinoma (MSI-H), Pancreatic Neuroendocrine Tumors (pNET)
Not yet recruitingObservational study
EUS-DFI in Solid Pancreatic Lesions
Pancreatic Neoplasms, Pancreatic Solid Lesions
RecruitingObservational study
An Artificial Intelligence System for Multimodal, Multi-class Diagnosing Solid Pancreatic Lesions Based on Endoscopic Ultrasound
Endoscopic Ultrasound (EUS), Solid Pancreatic Lesion
Not yet recruiting
22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions
Pancreatic Neoplasms, Mediastinal Neoplasms
Recruiting
RCT Comparing Accuracy Among Franseen, Forward-bevel Westcott, and Fork-tip EUS-FNB Needle in Diagnosis of Solid Pancreatic Lesions
Pancreatic Masses

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.

Mouen A Khashab, MD principal investigator

Johns Hopkins Univeristy

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Yield of Capillary Technique (time frame: up to 6 months). The study lists 5 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 NCT01936467, 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 13 Apr 2017.