Pancreatic TumorMousquetairesNCT03444051
Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors
An observational study of Pancreatic Tumor and Puncture, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Tumor, Puncture
- What is being tested?
- EUS-FNB with 20-gauge Procore® needle and EUS-FNB with 22-gauge Acquire® needle
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 15 Dec 2017
- Phase
- Observational
- 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
Study population: All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included. The use of EUS-FNB needle was determined during EUS if the examination confirmed the presence of a pancreatic or peri-pancreatic non-hyper-vascular mass (on Doppler examination). According to the period of admission, the 20-gauge Procore® (Wilson Cook Medical, Winston-Salem, NC) and 22-gauge Acquire® needles (Boston Scientific Natick, MA) were alternatively available depending on the order (made in batches of 5 units). So, patients were included either in the 20-gauge Procore® group or the 22-gauge Acquire® group. Patients could be switched via a crossover procedure to a second EUS-FNB with the competitive needle if the first one failed to give histologic mass characterization: failure was recorded to the first needle group, and the second EUS-FNB performed with the alternate needle was recorded in the other group.
Who may be able to join
- All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included
Who cannot join
- non-accessible pancreatic mass because of history of Billroth II or Roux-en-Y reconstruction
- coagulation disorders (such as partial thromboplastin time >42 seconds, prothrombin time [Quick value] <50%, platelet count <50 000/mm³), treatment with clopidogrel, pregnancy.
- patients <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the 20-gauge Procore® and 22-gauge Acquire® Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.
This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.
Read the detailed description
Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore®, and 34 with a 22-gauge Acquire®. Histological material was studied in a blinded manner with respect to the needle, and cumulative length of tissue core biopsies per needle pass was determined. Intra and inter-observer variability of this criterion was then evaluated.
- Conditions
- Pancreatic Tumor, Puncture
- Being tested
- EUS-FNB with 20-gauge Procore® needle, EUS-FNB with 22-gauge Acquire® needle
- Keywords
- EUS-FNB, comparative study
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNB with 20-gauge Procore® needleProcedure or surgery
Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore® needle
EUS-FNB with 22-gauge Acquire® needleProcedure or surgery
Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®
| Study group | Role | What they receive |
|---|---|---|
| 20-gauge Procore® | Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission:
34 punctures were performed with a 20-gauge Procore® during the period study Receives: Procedure: EUS-FNB with 20-gauge Procore® needle | |
| 22-gauge Acquire® | Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission:
34 punctures were performed with a 22-gauge Acquire® during the period study Receives: Procedure: EUS-FNB with 22-gauge Acquire® needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic mass anatomopathological characterization
pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass.
Measured: in the 7 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Mar 2017
- Primary completion1 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARSENTI, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444051
- Sponsor's protocol ID
- Mousquetaires
- Acronym
- Mousquetaires
- Status last verified
- Feb 2018
- First submitted
- 18 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the 20-gauge Procore® and 22-gauge Acquire® Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.
- ClinicalTrials.gov ID
- NCT03444051
- Acronym / sponsor ID
- Mousquetaires / Mousquetaires
- Conditions
- Pancreatic Tumor, Puncture
- Keywords
- EUS-FNB, comparative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 23 Feb 2018 (actual)
- 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.
This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.
Detailed description
Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore®, and 34 with a 22-gauge Acquire®. Histological material was studied in a blinded manner with respect to the needle, and cumulative length of tissue core biopsies per needle pass was determined. Intra and inter-observer variability of this criterion was then evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20-gauge Procore® | – | Procedure: EUS-FNB with 20-gauge Procore® needleBetween March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore® during the period study |
| 22-gauge Acquire® | – | Procedure: EUS-FNB with 22-gauge Acquire® needleBetween March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 22-gauge Acquire® during the period study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included. The use of EUS-FNB needle was determined during EUS if the examination confirmed the presence of a pancreatic or peri-pancreatic non-hyper-vascular mass (on Doppler examination). According to the period of admission, the 20-gauge Procore® (Wilson Cook Medical, Winston-Salem, NC) and 22-gauge Acquire® needles (Boston Scientific Natick, MA) were alternatively available depending on the order (made in batches of 5 units). So, patients were included either in the 20-gauge Procore® group or the 22-gauge Acquire® group. Patients could be switched via a crossover procedure to a second EUS-FNB with the competitive needle if the first one failed to give histologic mass characterization: failure was recorded to the first needle group, and the second EUS-FNB performed with the alternate needle was recorded in the other group.
Key inclusion criteria (1 listed)
- All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included
Key exclusion criteria (3 listed)
- non-accessible pancreatic mass because of history of Billroth II or Roux-en-Y reconstruction
- coagulation disorders (such as partial thromboplastin time >42 seconds, prothrombin time [Quick value] <50%, platelet count <50 000/mm³), treatment with clopidogrel, pregnancy.
- patients <18 years of age
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 |
|---|---|---|
| EUS-FNB with 20-gauge Procore® needlePuncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore® needle | Procedure or surgery | 20-gauge Procore® |
| EUS-FNB with 22-gauge Acquire® needlePuncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire® | Procedure or surgery | 22-gauge Acquire® |
Primary outcome
pancreatic mass anatomopathological characterization
Time frame: in the 7 days after procedure
pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass.
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 Feb 2018.
- Individual participant dataSharing planned: No
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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?
An observational study of Pancreatic Tumor and Puncture, run by Société Française d'Endoscopie Digestive 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 3 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 Feb 2018. 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.
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?
pancreatic mass anatomopathological characterization (time frame: in the 7 days after 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 23 Feb 2018.