- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01711294
Evaluation of PCLs Using Three EUS-FNA Needles
A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai, China, 200433
- Changhai Hospital
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Hyderabad, India, 500 082
- Asian Institute of Gastroenterology
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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New York
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New York, New York, United States, 10032
- New York Presbyterian Hospital/Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pancreatic cystic lesion measuring 13mm or greater in largest diameter.
- Indicated for EUS evaluation of the PCL including EUS-FNA.
- Age 18 years of age or older.
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
Exclusion Criteria:
- Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to the cyst.
- Requirement for anticoagulation using clopidogril, warfarin, or other long acting antiplatelet agents (with the exception of aspirin) that cannot be safely stopped according to institutional guidelines.
- Standard contraindications for EUS.
- Known pancreatic pseudocyst.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 19 G Flex Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G Flex)
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Fine Needle Aspiration of PCL with a 19 G Flex needle.
If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle.
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Active Comparator: 22 G Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22 G)
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Fine Needle Aspiration of PCL with a 22 G needle.
If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
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Active Comparator: 19 G Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G)
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Fine Needle Aspiration of PCL with a 19 G needle.
If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume
Time Frame: At procedure (Up to 1 hour)
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Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)
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At procedure (Up to 1 hour)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Related Adverse Events
Time Frame: 30 days
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Adverse events related to study procedure or study device were tabulated.
Adverse events were assessed from the index procedure up to 30 days post procedure.
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30 days
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Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure
Time Frame: Procedure (Up to 1 hour)
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Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure.
Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis.
The volume unit is cc.
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Procedure (Up to 1 hour)
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Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL
Time Frame: Procedure (up to 1 hour)
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Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more)
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Procedure (up to 1 hour)
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Number of Participants With PCL Reached/Penetrated
Time Frame: Procedure (Up to 1 hour)
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Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.
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Procedure (Up to 1 hour)
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Number of EUS-FNA Needle Passes at Initial Procedure.
Time Frame: Procedure (Up to 1 hour)
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Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.
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Procedure (Up to 1 hour)
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Number of EUS-FNA Needles Used at Initial Procedure.
Time Frame: Procedure (Up to 1 hour)
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Total number of EUS-FNA needles used across all participants at the initial procedure.
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Procedure (Up to 1 hour)
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Time Needed for Aspiration for Each Needle Pass at Initial Procedure.
Time Frame: Procedure (Up to 1 hour)
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Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst. |
Procedure (Up to 1 hour)
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Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.
Time Frame: Procedure (Up to 1 hour)
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Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.
Time of first needle pass in is time of the first needle puncture into the cyst lumen.
Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.
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Procedure (Up to 1 hour)
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Number of Needles With Needle Insertion Rated as Excellent/Very Good
Time Frame: Procedure (Up to 1 hour)
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Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.
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Procedure (Up to 1 hour)
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Number of Needles With Needle Removal Rated as Excellent/Very Good
Time Frame: Procedure (Up to 1 hour)
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Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.
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Procedure (Up to 1 hour)
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Number of Needles With Needle Visualization Rated as Excellent/Very Good
Time Frame: Procedure (Up to 1 hour)
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Number of needles rated either Excellent or Very good for visualization at the initial procedure.
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Procedure (Up to 1 hour)
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Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles
Time Frame: up to 2 years
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In order to assess the accuracy of EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state, the Disease State per EUS-FNA measure was compared to a reference diagnosis.
The reference diagnostic standard was diagnosis from a surgical specimen histology, the true gold standard for cases that evolved to surgical resection within the follow-up of the study.
For cases that did not progress to surgery within the follow-up period, the reference diagnostic standard was a composite diagnosis by a consensus board.
The consensus board consisted of 3 experts who were blinded to the type of needle used.
The consensus board diagnoses of disease state were based on baseline medical history, EUS and cross sectional imaging of the cyst, and aspirate characteristics (i.e.
aspirate color and viscosity).
If the EUS-FNA diagnosis matches with the histopathology or consensus board diagnosis, then the participant will be counted as having accurate diagnosis.
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up to 2 years
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Number of Participants Requiring Post EUS-FNA Patient Management
Time Frame: 30 days
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Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal).
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30 days
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Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings
Time Frame: Procedure - 30 days after procedure
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Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings.
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Procedure - 30 days after procedure
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Rate of Cross-over to Salvage Arm
Time Frame: Procedure (Immediate)
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In the case of inability to access the pancreatic cystic lesion or to attain complete cyst aspiration, salvage aspiration procedure should be performed.
Patients randomized to 19G Flex should undergo a salvage procedure with 22G or 19G needle (needle choice at discretion of physician); patients randomized to 22G or 19G should undergo salvage procedure with 19G Flex needle.
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Procedure (Immediate)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael B Wallace, MD,MPH, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 90869947
- E7084 (Other Identifier: Boston Scientific)
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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