Pancreatic TumorPhase 3PICORENCT01479803
Comparison of Two Needles (ProCore vs EchoTip) for the Diagnosis of Pancreatic Solid Mass Under EUS
A Phase 3 study of Pancreatic Tumor and Fine Needle Aspiration, run by VANBIERVLIET at 1 site in France.
Trial summary
The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22 gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Tumor, Fine Needle Aspiration, Endoscopic Ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Oct 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid tumor of the pancreas (<50% share or anechoic fluid) to receive a biopsy under endoscopic ultrasonography (EUS)
Who cannot join
- Contraindications to the achievement of an upper gastrointestinal endoscopy
- Haemorrhagic disease, disorder of hemostasis and coagulation (PT <60%, CaT> 40 sec. and platelets <60000/mm3)
- Pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARATIVE STUDY OF DIAGNOSTIC VALUE FOR THE ECHOTIP® PROCORE™ 22 Gauge NEEDLE VERSUS ECHOTIP® 22 Gauge IN THE DIAGNOSIS OF PANCREATIC SOLID TUMORS UNDER ENDOSCOPIC ULTRASONOGRAPHY : THE "PICORE" STUDY
The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22 gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). In case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is severe and extensive treatment, remains important. To improve the sensitivity of EUS echo endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE Mark in the field of EUS. This instrument combines the comfortable and handy size of 22 Gauge and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy. In addition, a single pass through the tumor is achieved with this hand against several (2-3 minimum) with the current hardware. The theoretical goal is to have a tissue material more abundant during the sampling, without increasing morbidity and increase the diagnostic accuracy. A preliminary prospective study with this material has shown interesting results (increase the diagnostic accuracy of 15%).
To determine the diagnostic gain with this new hand, it seemed essential to propose a prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles on the same injury can limit the effect of variability between patients and thereby have a better power for the investigators study without increasing the risk of complications (the needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic solid tumors is one that poses the biggest diagnostic problem still present in the investigators daily practice. The aim of this study is to compare the diagnostic accuracy of the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for pancreatic solid tumors under EUS.
- Being tested
- Puncture with fine needle aspiration under endoscopic ultrasonographic control
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puncture with fine needle aspiration under endoscopic ultrasonographic controlProcedure or surgery
Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control Passage in the same pancreatic mass of first EchoTip HD Procore then EchoTip 22 Gauge or vice versa according to the randomization
| Study group | Role | What they receive |
|---|---|---|
| EchoTip HD ProCore 22 Gauge | Active comparator | first passage in the pancreatic tumor with the EchoTip HD ProCore 22 Gauge then with the EchoTip 22 Gauge Receives: Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control |
| Echo Tip 22 Gauge | Active comparator | First passage through the tumor with the EchoTip 22 Gauge then with Echotip HD ProCore 22 Gauge Receives: Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of fine needle aspiration Echo Tip® HD ProCore™ versus EchoTip® in the etiological cyto histological in pancreatic solid tumors explored under endoscopy ultrasonography.
Measured: 6 months
Secondary outcomes (4)
Immediate morbidity per procedure of both techniques and delayed morbidity (up to D30) of the complete procedure (corresponding to all of the discussion with the punctures of 2 needles).
Adverse effects (%, number of event for each needle passage) during the procedure or during the follow up period (30 days)
Measured: 2 minutes and 30 days
Quality of histological specimen obtained with the 2 needles
Visual analogic scale and Maier score used for this point
Measured: 10 days
Dysfunction in two type of needle biopsy
failure or difficulty reports with each needle (%)
Measured: Day one
ease of puncture between the 2 types of equipment.
Visual analogic scale
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
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 TumorStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- VANBIERVLIET
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, VANBIERVLIET, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479803
- Sponsor's protocol ID
- 2011-A00578-33
- Acronym
- PICORE
- Status last verified
- Apr 2014
- First submitted
- 20 Oct 2011
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vanbiervliet G, Napoleon B, Saint Paul MC, Sakarovitch C, Wangermez M, Bichard P, Subtil C, Koch S, Grandval P, Gincul R, Karsenti D, Heyries L, Duchmann JC, Bourgaux JF, Levy M, Calament G, Fumex F, Pujol B, Lefort C, Poincloux L, Pagenault M, Bonin EA, Fabre M, Barthet M. Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study. Endoscopy. 2014 Dec;46(12):1063-70. doi: 10.1055/s-0034-1377559. Epub 2014 Aug 6.
PubMed 25098612
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE STUDY OF DIAGNOSTIC VALUE FOR THE ECHOTIP® PROCORE™ 22 Gauge NEEDLE VERSUS ECHOTIP® 22 Gauge IN THE DIAGNOSIS OF PANCREATIC SOLID TUMORS UNDER ENDOSCOPIC ULTRASONOGRAPHY : THE "PICORE" STUDY
- ClinicalTrials.gov ID
- NCT01479803
- Acronym / sponsor ID
- PICORE / 2011-A00578-33
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- VANBIERVLIETUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Nov 2011 (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.
The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22 gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). In case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is severe and extensive treatment, remains important. To improve the sensitivity of EUS echo endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE Mark in the field of EUS. This instrument combines the comfortable and handy size of 22 Gauge and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy. In addition, a single pass through the tumor is achieved with this hand against several (2-3 minimum) with the current hardware. The theoretical goal is to have a tissue material more abundant during the sampling, without increasing morbidity and increase the diagnostic accuracy. A preliminary prospective study with this material has shown interesting results (increase the diagnostic accuracy of 15%).
To determine the diagnostic gain with this new hand, it seemed essential to propose a prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles on the same injury can limit the effect of variability between patients and thereby have a better power for the investigators study without increasing the risk of complications (the needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic solid tumors is one that poses the biggest diagnostic problem still present in the investigators daily practice. The aim of this study is to compare the diagnostic accuracy of the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for pancreatic solid tumors under EUS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EchoTip HD ProCore 22 Gauge | Active comparator | Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic controlfirst passage in the pancreatic tumor with the EchoTip HD ProCore 22 Gauge then with the EchoTip 22 Gauge |
| Echo Tip 22 Gauge | Active comparator | Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic controlFirst passage through the tumor with the EchoTip 22 Gauge then with Echotip HD ProCore 22 Gauge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Solid tumor of the pancreas (<50% share or anechoic fluid) to receive a biopsy under endoscopic ultrasonography (EUS)
Key exclusion criteria (4 listed)
- Contraindications to the achievement of an upper gastrointestinal endoscopy
- Haemorrhagic disease, disorder of hemostasis and coagulation (PT <60%, CaT> 40 sec. and platelets <60000/mm3)
- Pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)
- Pregnant or lactating
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 |
|---|---|---|
| Puncture with fine needle aspiration under endoscopic ultrasonographic controlPuncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control Passage in the same pancreatic mass of first EchoTip HD Procore then EchoTip 22 Gauge or vice versa according to the randomization | Procedure or surgery | Echo Tip 22 Gauge, EchoTip HD ProCore 22 Gauge |
Primary outcome
Diagnostic accuracy of fine needle aspiration Echo Tip® HD ProCore™ versus EchoTip® in the etiological cyto histological in pancreatic solid tumors explored under endoscopy ultrasonography.
Time frame: 6 months
4 secondary outcomes
Immediate morbidity per procedure of both techniques and delayed morbidity (up to D30) of the complete procedure (corresponding to all of the discussion with the punctures of 2 needles).
Time frame: 2 minutes and 30 days
Quality of histological specimen obtained with the 2 needles
Time frame: 10 days
Dysfunction in two type of needle biopsy
Time frame: Day one
ease of puncture between the 2 types of equipment.
Time frame: day one
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 23 Apr 2014.
- Derived from this study: PubMed 25098612Vanbiervliet G, Napoleon B, Saint Paul MC, Sakarovitch C, Wangermez M, Bichard P, Subtil C, Koch S, Grandval P, Gincul R, Karsenti D, Heyries L, Duchmann JC, Bourgaux JF, Levy M, Calament G, Fumex F, Pujol B, Lefort C, Poincloux L, Pagenault M, Bonin EA, Fabre M, Barthet M. Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study. Endoscopy. 2014 Dec;46(12):1063-70. doi: 10.1055/s-0034-1377559. Epub 2014 Aug 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Pancreatic Tumor and Fine Needle Aspiration, run by VANBIERVLIET at 1 site in France.
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 4 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 23 Apr 2014. 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 France. 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?
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?
Diagnostic accuracy of fine needle aspiration Echo Tip® HD ProCore™ versus EchoTip® in the etiological cyto histological in pancreatic solid tumors explored under endoscopy ultrasonography. (time frame: 6 months). 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 NCT01479803, 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 23 Apr 2014.