22 G - 25 G SINS Trial for Pancreatic Masses (SINS)

February 12, 2019 updated by: AdventHealth

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

  1. After written informed consent is taken, Endoscopic Ultrasound (EUS) will be performed under conscious sedation.
  2. 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).
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. After the appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.
  10. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
352

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA
  2. Age ≥ 19 years

Exclusion Criteria:

  1. Age <19 years
  2. Unable to safely undergo EUS for any reason
  3. Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
  4. Unable to provide consent for any reason
  5. Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 22 gauge with suction
EUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction.
Procedure: EUS-FNA of pancreatic masses
EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.
Device: 22 gauge needle
Active Comparator: 22 gauge without suction
EUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction.
Procedure: EUS-FNA of pancreatic masses
EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.
Device: 22 gauge needle
Active Comparator: 25 gauge with suction
EUS-FNA of pancreatic masses will be performed with a 25 gauge needle using suction.
Procedure: EUS-FNA of pancreatic masses
EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.
Device: 25 gauge needle
Active Comparator: 25 gauge without suction
EUS-FNA of pancreatic masses will be performed with a 25 gauge needle without suction.
Procedure: EUS-FNA of pancreatic masses
EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.
Device: 25 gauge needle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
7 days (cell block processing in lab)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnostic adequacy of FNA cytology
Time Frame: 24 hours
1. Diagnostic adequacy of FNA cytology samples and comparison between the two needle sizes and the effect of application of suction
24 hours
Median number of passes to diagnosis
Time Frame: 24 hours
2. Median no. of passes required to obtain diagnostically adequate cytological samples, and comparison between the two needle sizes and suction vs. no suction
24 hours
Specimen bloodiness
Time Frame: 24 hours
3. Specimen bloodiness and comparison between the two needle sizes and two techniques (with and without suction)
24 hours
Rate of needle dysfunction
Time Frame: 24 hours
4. Rate of needle dysfunction and technical failure, and comparison between the two needle sizes and two techniques (with and without suction)
24 hours
Rate of complications
Time Frame: 3 days
5. Rate of complications following EUS-FNA, and comparison between the two needle sizes and two techniques (with and without suction)
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AdventHealth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shyam S Varadarajulu, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 618366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share Individual Participant Data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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