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

Pancreas Cancer Clinical Trial

— HISTOPAN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567863
• Other study ID #: 2018-A00276-49
• Status: Completed
• Phase: N/A
• Start date: June 24, 2018
• Est. completion date: September 29, 2019

Study information

• Verified date: September 2019
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 29, 2019
• Est. primary completion date: September 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Cancer
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Device:
• 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)

Locations

Country	Name	City	State
France	David Karsenti	Charenton-le-Pont	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative length of tissue core biopsies per needle pass	cumulative length of tissue core biopsies per needle pass in mm	in the 7 days after procedure
Secondary	Presence of core biopsy specimen	Presence of core biopsy specimen	in the 7 days after procedure
Secondary	Sensitivity	EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas	in the 7 days or 6 months
Secondary	Specificity	EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas	in the 7 days or 6 months
Secondary	Positive Predictive Value	EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas	in the 7 days or 6 months
Secondary	Negative Predictive Value	EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas	in the 7 days or 6 months
Secondary	Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface	Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All Core biopsies	6 months
Secondary	Success rate of isolation of tumor cells	Success rate of isolation of tumor cells	6 months
Secondary	Morbidity	Puncture Morbidity (acute pancreatitis, haemorrhage)	7 days
Secondary	Feasibility	Technical failure rate of puncture because of a impossibility to access to pancreatic mass with the needle (due to the needle stiffness)	during procedure
Secondary	inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)	inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)	7 days
Secondary	determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes	determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes	6 months
Secondary	intra-observer evaluation of the anatomopathological criteria used	intra-observer evaluation of the anatomopathological criteria used	7 days