Clinical trial NCT03567863: Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles
Official title: Multicentric Randomized Study Comparing the Histological and Molecular Material Quality Obtained by EUS-FNB of Pancreatic Mass With Two "Biopsic" Needles: the 20-gauge Procore® (Cook) and the 22-gauge Acquire® (Boston Scientific)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Cancer
Pancreatic Adenocarcinoma
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Multicenter randomized prospective study

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

Detailed description: Type of study:

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

Eligibility criteria: Inclusion Criteria:

* Patient admitted to one of the investigative centers for endoscopic pancreatic puncture during the period from April 1, 2018 to April 1, 2019
* 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:

* Patients punctured with an extra-pancreatic mass
* 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

Primary outcomes:
measure: cumulative length of tissue core biopsies per needle pass
timeFrame: in the 7 days after procedure
Secondary outcomes:
measure: Presence of core biopsy specimen
timeFrame: in the 7 days after procedure
measure: Sensitivity
timeFrame: in the 7 days or 6 months
measure: Specificity
timeFrame: in the 7 days or 6 months
measure: Positive Predictive Value
timeFrame: in the 7 days or 6 months
measure: Negative Predictive Value
timeFrame: in the 7 days or 6 months
measure: Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface
timeFrame: 6 months
measure: Success rate of isolation of tumor cells
timeFrame: 6 months
measure: Morbidity
timeFrame: 7 days
measure: Feasibility
timeFrame: during procedure
measure: inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)
timeFrame: 7 days
measure: determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
timeFrame: 6 months
measure: intra-observer evaluation of the anatomopathological criteria used
timeFrame: 7 days
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: David Karsenti
state: Ile De France
Study officials:
affiliation: Société Française d'Endoscopie Digestive
name: David Karsenti, MD
role: PRINCIPAL_INVESTIGATOR
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