Pancreas Cancer, Pancreatic Adenocarcinoma
Conditions
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
Interventions
DEVICE20-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)
DEVICE22-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)
Sponsors
Société Française d'Endoscopie Digestive
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
the order of use of the 2 needles is not communicated to the cytologist
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative length of tissue core biopsies per needle pass | in the 7 days after procedure | cumulative length of tissue core biopsies per needle pass in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | in the 7 days or 6 months | EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas |
| Specificity | in the 7 days or 6 months | EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas |
| Positive Predictive Value | in the 7 days or 6 months | EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas |
| Negative Predictive Value | in the 7 days or 6 months | EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas |
| Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface | 6 months | Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All Core biopsies |
| Presence of core biopsy specimen | in the 7 days after procedure | Presence of core biopsy specimen |
| Morbidity | 7 days | Puncture Morbidity (acute pancreatitis, haemorrhage) |
| Feasibility | during procedure | Technical failure rate of puncture because of a impossibility to access to pancreatic mass with the needle (due to the needle stiffness) |
| inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass) | 7 days | inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass) |
| determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes | 6 months | determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes |
| intra-observer evaluation of the anatomopathological criteria used | 7 days | intra-observer evaluation of the anatomopathological criteria used |
| Success rate of isolation of tumor cells | 6 months | Success rate of isolation of tumor cells |
Countries
France
Outcome results
None listed