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

September 29, 2019 updated by: KARSENTI, Société Française d'Endoscopie Digestive

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Charenton-le-Pont, Ile De France, France, 94220
        • David Karsenti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A

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®
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)
Active Comparator: Group B

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®
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative length of tissue core biopsies per needle pass
Time Frame: in the 7 days after procedure
cumulative length of tissue core biopsies per needle pass in mm
in the 7 days after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société Française d'Endoscopie Digestive

Investigators

  • Principal Investigator: David KARSENTI, MD, Société Française d'Endoscopie Digestive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2018

Primary Completion (Actual)

September 29, 2019

Study Completion (Actual)

September 29, 2019

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 29, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A00276-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Adenocarcinoma

Clinical Trials on 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe