Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles (HISTOPAN)
Primary Purpose
Pancreas Cancer, Pancreatic Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreas Cancer
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
Sites / Locations
- David Karsenti
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm 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®
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®
Outcomes
Primary Outcome Measures
cumulative length of tissue core biopsies per needle pass
cumulative length of tissue core biopsies per needle pass in mm
Secondary Outcome Measures
Presence of core biopsy specimen
Presence of core biopsy specimen
Sensitivity
EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas
Specificity
EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas
Positive Predictive Value
EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas
Negative Predictive Value
EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas
Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface
Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All Core biopsies
Success rate of isolation of tumor cells
Success rate of isolation of tumor cells
Morbidity
Puncture Morbidity (acute pancreatitis, haemorrhage)
Feasibility
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)
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
determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
intra-observer evaluation of the anatomopathological criteria used
intra-observer evaluation of the anatomopathological criteria used
Full Information
NCT ID
NCT03567863
First Posted
May 29, 2018
Last Updated
September 29, 2019
Sponsor
Société Française d'Endoscopie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT03567863
Brief Title
Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 24, 2018 (Actual)
Primary Completion Date
September 29, 2019 (Actual)
Study Completion Date
September 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Société Française d'Endoscopie Digestive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
the order of use of the 2 needles is not communicated to the cytologist
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm 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®
Arm Title
Group B
Arm Type
Active Comparator
Arm 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®
Intervention Type
Device
Intervention Name(s)
20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
Intervention Description
The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)
Intervention Type
Device
Intervention Name(s)
22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
Intervention Description
The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)
Primary Outcome Measure Information:
Title
cumulative length of tissue core biopsies per needle pass
Description
cumulative length of tissue core biopsies per needle pass in mm
Time Frame
in the 7 days after procedure
Secondary Outcome Measure Information:
Title
Presence of core biopsy specimen
Description
Presence of core biopsy specimen
Time Frame
in the 7 days after procedure
Title
Sensitivity
Description
EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas
Time Frame
in the 7 days or 6 months
Title
Specificity
Description
EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas
Time Frame
in the 7 days or 6 months
Title
Positive Predictive Value
Description
EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas
Time Frame
in the 7 days or 6 months
Title
Negative Predictive Value
Description
EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas
Time Frame
in the 7 days or 6 months
Title
Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface
Description
Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All Core biopsies
Time Frame
6 months
Title
Success rate of isolation of tumor cells
Description
Success rate of isolation of tumor cells
Time Frame
6 months
Title
Morbidity
Description
Puncture Morbidity (acute pancreatitis, haemorrhage)
Time Frame
7 days
Title
Feasibility
Description
Technical failure rate of puncture because of a impossibility to access to pancreatic mass with the needle (due to the needle stiffness)
Time Frame
during procedure
Title
inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)
Description
inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)
Time Frame
7 days
Title
determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
Description
determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
Time Frame
6 months
Title
intra-observer evaluation of the anatomopathological criteria used
Description
intra-observer evaluation of the anatomopathological criteria used
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Karsenti, MD
Organizational Affiliation
Société Française d'Endoscopie Digestive
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Karsenti
City
Charenton-le-Pont
State/Province
Ile De France
ZIP/Postal Code
94220
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles
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