Comparison of Two Needles (ProCore vs EchoTip) for the Diagnosis of Pancreatic Solid Mass Under EUS (PICORE)

April 22, 2014 updated by: VANBIERVLIET

COMPARATIVE STUDY OF DIAGNOSTIC VALUE FOR THE ECHOTIP® PROCORE™ 22 Gauge NEEDLE VERSUS ECHOTIP® 22 Gauge IN THE DIAGNOSIS OF PANCREATIC SOLID TUMORS UNDER ENDOSCOPIC ULTRASONOGRAPHY : THE "PICORE" STUDY

The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22 gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). In case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is severe and extensive treatment, remains important. To improve the sensitivity of EUS echo endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE Mark in the field of EUS. This instrument combines the comfortable and handy size of 22 Gauge and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy. In addition, a single pass through the tumor is achieved with this hand against several (2-3 minimum) with the current hardware. The theoretical goal is to have a tissue material more abundant during the sampling, without increasing morbidity and increase the diagnostic accuracy. A preliminary prospective study with this material has shown interesting results (increase the diagnostic accuracy of 15%).

To determine the diagnostic gain with this new hand, it seemed essential to propose a prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles on the same injury can limit the effect of variability between patients and thereby have a better power for the investigators study without increasing the risk of complications (the needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic solid tumors is one that poses the biggest diagnostic problem still present in the investigators daily practice. The aim of this study is to compare the diagnostic accuracy of the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for pancreatic solid tumors under EUS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

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
      • Nice Cedex 3, France, 06202
        • Hôpital L'Archet 2, CHU Nice, BP 3079

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Solid tumor of the pancreas (<50% share or anechoic fluid) to receive a biopsy under endoscopic ultrasonography (EUS)

Exclusion Criteria:

  • Contraindications to the achievement of an upper gastrointestinal endoscopy
  • Haemorrhagic disease, disorder of hemostasis and coagulation (PT <60%, CaT> 40 sec. and platelets <60000/mm3)
  • Pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)
  • Pregnant or lactating

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: EchoTip HD ProCore 22 Gauge
first passage in the pancreatic tumor with the EchoTip HD ProCore 22 Gauge then with the EchoTip 22 Gauge
Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control
Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control Passage in the same pancreatic mass of first EchoTip HD Procore then EchoTip 22 Gauge or vice versa according to the randomization
ACTIVE_COMPARATOR: Echo Tip 22 Gauge
First passage through the tumor with the EchoTip 22 Gauge then with Echotip HD ProCore 22 Gauge
Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control
Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control Passage in the same pancreatic mass of first EchoTip HD Procore then EchoTip 22 Gauge or vice versa according to the randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of fine needle aspiration Echo Tip® HD ProCore™ versus EchoTip® in the etiological cyto histological in pancreatic solid tumors explored under endoscopy ultrasonography.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate morbidity per procedure of both techniques and delayed morbidity (up to D30) of the complete procedure (corresponding to all of the discussion with the punctures of 2 needles).
Time Frame: 2 minutes and 30 days
Adverse effects (%, number of event for each needle passage) during the procedure or during the follow up period (30 days)
2 minutes and 30 days
Quality of histological specimen obtained with the 2 needles
Time Frame: 10 days
Visual analogic scale and Maier score used for this point
10 days
Dysfunction in two type of needle biopsy
Time Frame: Day one
failure or difficulty reports with each needle (%)
Day one
ease of puncture between the 2 types of equipment.
Time Frame: day one
Visual analogic scale
day one

Collaborators and Investigators

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

Sponsor

VANBIERVLIET

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

October 1, 2011

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (ESTIMATE)

November 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00578-33

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.

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