Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles (HISTOPAN)

Société Française d'Endoscopie Digestive

Status: Completed

Conditions: Pancreatic Adenocarcinoma; Pancreas Cancer

Treatments: Device: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®; Device: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®

Study type: Interventional

Funder types: Other

Identifiers

NCT03567863

2018-A00276-49

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group A

Active Comparator group

Description:

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®

Treatment:

Device: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®

Group B

Active Comparator group

Description:

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®

Treatment:

Device: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®