Pancreatic or Peripancreatic LesionsNCT01916421
The Cellularity Yield of Three Different 22-gauge FNA Needles
A study testing Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) in people with Pancreatic or Peripancreatic Lesions and Lesions in the Esophagus, Stomach, Duodenum or Rectum, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a flexible tube with a camera and small ultrasound machine at its end )requires the use of a needle for taking the sample from the lesion or what we call "Fine needle aspiration (FNA)". Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Pancreatic or Peripancreatic Lesions, Lesions in the Esophagus, Stomach, Duodenum or Rectum, Mediastinal ( Chest) Masses
- What is being tested?
- Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2014
- 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-88) who are undergoing EUS FNA of pancreatic or peripancreatic lesions
- Adult patients (18-88) who are undergoing EUS FNA of submucosal masses in the esophagus, stomach, duodenum or rectum
- Adult patients (18-88) who are undergoing EUS FNA of mediastinal masses.
- Adult patients (18-88) who are undergoing EUS FNA of enlarged lymph nodes
Who cannot join
- Patients younger than 18 yrs old or older than 88 yrs.
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, 79905
About this study
Official title: The Cellularity Yield of Three Different 22-gauge Endoscopic Ultrasound Fine Needle Aspiration Needles
Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a flexible tube with a camera and small ultrasound machine at its end )requires the use of a needle for taking the sample from the lesion or what we call "Fine needle aspiration (FNA)". Currently, FNA is done by three commercially available needles. These needles are used routinely in our institution for FNA. The data regarding the safety and the successfulness of any of these needles are lacking. We sought to compare all three commercially available needles in a prospective manner.
Read the detailed description
The following are being done only for research purposes; prior to performing the FNA, The patient will be randomized to one of the three commercially available FNA needles. At this time, all needles are considered equivalent and there is no medical necessity to pick one over another. The sample obtained by the needle will be assigned a quality score based on certain parameters of the sample such as the abundance of diagnostic cells and the presence of blood. We are going to collect certain information about your procedure such as the complications of the procedure, number of needle passes and final diagnosis.
- Conditions
- Pancreatic or Peripancreatic Lesions, Lesions in the Esophagus, Stomach, Duodenum or Rectum, Mediastinal ( Chest) Masses, Enlarged Lymph Nodes
- Being tested
- Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
- Keywords
- Pancreatic adenocarcinoma, lymphadenopathy, Endoscopic ultrasound
- Medical subject headings
- Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| EZ Shot | Active comparator | Not described Receives: Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) |
| Expect™ | Active comparator | Not described Receives: Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) |
| EchoTip® Ultra | Active comparator | Not described Receives: Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles
Cellularity score will be assessed by the cytopathologist using the scoring system from 0 to 10 score. This scoring system evaluate the amount of blood, malignant cells and contaminant cells. The system is a modified form Mair et al study. " Mair S, Dunbar F, Becker PJ, Du Plessis W. Fine needle cytology--is aspiration suction necessary? A study of 100 masses in various sites. Acta cytologica 1989;33:809-13."
Measured: 2 days after the procedure
Secondary outcomes (3)
Compare the complication rate between the three commercially available 22 gauge EUS needles.
The patient will be contacted after the procedure by one week to review any procedure complications. The patient's medical records may be reviewed for up to 6 months after the procedure to review the surgical resection results or the long-term follow-up results. If the patient receives his further care in another hospital, the patient will be contacted by phone for follow-up for a maximum period of 6 months.
Measured: up to 1 month after the procedure
Compare the number of FNA needles passes required to reach the diagnosis.
The number of passes required to reach the diagnosis
Measured: During the procedure ( 30 -45 minutes)
Compare the technical success of the three commercially available 22 gauge EUS needles
The ability of the needle to perform the intended purpose of the procedure ( reach the lesion and obtain sufficient tissues)
Measured: During the procedure ( 30-45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic or Peripancreatic LesionsStudies 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
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Mohamed O Othman, MD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916421
- Sponsor's protocol ID
- E12097
- Status last verified
- May 2017
- First submitted
- 23 Jun 2013
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cellularity Yield of Three Different 22-gauge Endoscopic Ultrasound Fine Needle Aspiration Needles
- ClinicalTrials.gov ID
- NCT01916421
- Acronym / sponsor ID
- E12097
- Conditions
- Pancreatic or Peripancreatic Lesions, Lesions in the Esophagus, Stomach, Duodenum or Rectum, Mediastinal ( Chest) Masses, Enlarged Lymph Nodes
- Keywords
- Pancreatic adenocarcinoma, lymphadenopathy, Endoscopic ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Aug 2013 (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.
Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a flexible tube with a camera and small ultrasound machine at its end )requires the use of a needle for taking the sample from the lesion or what we call "Fine needle aspiration (FNA)". Currently, FNA is done by three commercially available needles. These needles are used routinely in our institution for FNA. The data regarding the safety and the successfulness of any of these needles are lacking. We sought to compare all three commercially available needles in a prospective manner.
Detailed description
The following are being done only for research purposes; prior to performing the FNA, The patient will be randomized to one of the three commercially available FNA needles. At this time, all needles are considered equivalent and there is no medical necessity to pick one over another. The sample obtained by the needle will be assigned a quality score based on certain parameters of the sample such as the abundance of diagnostic cells and the presence of blood. We are going to collect certain information about your procedure such as the complications of the procedure, number of needle passes and final diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EZ Shot | Active comparator | Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) |
| Expect™ | Active comparator | Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) |
| EchoTip® Ultra | Active comparator | Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18-88) who are undergoing EUS FNA of pancreatic or peripancreatic lesions
- Adult patients (18-88) who are undergoing EUS FNA of submucosal masses in the esophagus, stomach, duodenum or rectum
- Adult patients (18-88) who are undergoing EUS FNA of mediastinal masses.
- Adult patients (18-88) who are undergoing EUS FNA of enlarged lymph nodes
Key exclusion criteria (2 listed)
- Patients younger than 18 yrs old or older than 88 yrs.
- Pregnant patients
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 |
|---|---|---|
| Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) | Procedure or surgery | EZ Shot, EchoTip® Ultra, Expect™ |
Primary outcome
1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles
Time frame: 2 days after the procedure
Cellularity score will be assessed by the cytopathologist using the scoring system from 0 to 10 score. This scoring system evaluate the amount of blood, malignant cells and contaminant cells. The system is a modified form Mair et al study. " Mair S, Dunbar F, Becker PJ, Du Plessis W. Fine needle cytology--is aspiration suction necessary? A study of 100 masses in various sites. Acta cytologica 1989;33:809-13."
3 secondary outcomes
Compare the complication rate between the three commercially available 22 gauge EUS needles.
Time frame: up to 1 month after the procedure
Compare the number of FNA needles passes required to reach the diagnosis.
Time frame: During the procedure ( 30 -45 minutes)
Compare the technical success of the three commercially available 22 gauge EUS needles
Time frame: During the procedure ( 30-45 minutes)
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 17 May 2017.
- Individual participant dataSharing planned: No
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.
Mohamed O Othman, MD principal investigator
Texas Tech University Health Sciences Center, El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) in people with Pancreatic or Peripancreatic Lesions and Lesions in the Esophagus, Stomach, Duodenum or Rectum, run by Texas Tech University Health Sciences Center, El Paso 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 4 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 17 May 2017. 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?
1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles (time frame: 2 days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2017.