Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles
NCT ID: NCT03567863
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-06-24
2019-09-29
Brief Summary
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Criteria for inclusion:
Patients admitted for EUS-FNB of a pancreatic mass
Goals of the study:
To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific.
Main criterion:
\- Biopsy core length of target tissue obtained by needle pass
Number of patients:
60 patients
Duration of the study:
1 year
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Detailed Description
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Multicenter randomized prospective study
Criteria for inclusion:
Patients admitted for ENDOSCOPIC ULTRASOUND FINE NEEDLE BIOPSY (EUS-FNB) of a pancreatic mass
Exclusion criteria:
Patients with an extra-pancreatic mass puncture Echendoscopic puncture contraindication or vascular interposition
Goals of the study:
To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific.
Evaluation criteria :
Main criterion:
\- Biopsy core length of target tissue obtained by needle pass
Secondary criteria
* Presence of a core biopsy specimen
* Sensitivity of EUS-FNB for the diagnosis of adenocarcinoma of the pancreas
* False negative rate, Negative predictive value for the diagnosis of pancreatic adenocarcinoma
* Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All core biopsy specimens
* Success rate of isolation of tumor cells and determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
* Immediate complications of puncture
* Variation in the quality of the puncture following the trans-duodenal or trans-gastric access route
* Technical failure rate of puncture
* Optional: inter and intra-observer evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle passage)
Number of patients:
60 patients
Duration of the study:
1 year
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
DOUBLE
Study Groups
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Group A
The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)
20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)
Group B
The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)
22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)
Interventions
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20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)
22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)
Eligibility Criteria
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Inclusion Criteria
* Patient whose age is greater than or equal to 18 years and less than 90 years
* Patient ASA 1, ASA 2, ASA 3 (ASA: American Society of Anaesthesiologists Classification)
* Lack of participation in another clinical study
* Signed informed consent
Exclusion Criteria
* Patient under the age of 18 or over 90
* Patient ASA 4, ASA 5
* Pregnant woman
* Patient with coagulation abnormalities preventing puncture: TP \<50%, Platelets \<50000 / mm3, effective anticoagulation in progress, clopidogrel in progress
* Vascular or ductal or surgical fixation (Billroth II, Roux in Y) preventing endoscopic access to the lesion to be punctured
* Patient unable to personally consent
18 Years
90 Years
ALL
No
Sponsors
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Société Française d'Endoscopie Digestive
OTHER
Responsible Party
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KARSENTI
MD, Principal Investigator
Principal Investigators
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David Karsenti, MD
Role: PRINCIPAL_INVESTIGATOR
Société Française d'Endoscopie Digestive
Locations
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David Karsenti
Charenton-le-Pont, Île-de-France Region, France
Countries
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References
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Other Identifiers
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2018-A00276-49
Identifier Type: -
Identifier Source: org_study_id
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