Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis (EASYFLEX)

April 19, 2017 updated by: Christian BOUSTIERE, French Society of Digestive Endoscopy

Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.

The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate < 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "ProCore" or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.

Study Type

Interventional

Enrollment (Actual)

124

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
      • Marseille, France, 13008
        • Hopital Saint Joseph

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:

  • patient with solid tumor of pancreas who has to receive a biopsy under endoscopic ultrasound (EUS)
  • patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria:

  • patient who participates in an other study
  • patient mentally or legally incapacitated
  • patient with contraindications to the achievement of upper gastrointestinal endoscopy
  • patient with haemorrhagic disease, disorder of hemostasis and coagulation (TP<60%, TCA>40sec and platelets <60000/mm3)
  • patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure
  • patient with pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)
  • patient pregnant or lactating women

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 19G flex needle puncture
puncture of head of pancreas
Device: puncture of head of pancreas

puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.

randomization: puncture with either 22G needle or 19G flex needle
Active Comparator: 22G needle puncture
puncture of head of pancreas
Device: puncture of head of pancreas

puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.

randomization: puncture with either 22G needle or 19G flex needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of 19G Flex Expect needle in the histological diagnosis of pancreatic solid tumors of the head of pancreas
Time Frame: 10 days
accuracy and diagnostic gain of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic tumors of the head of pancreas: comparison between 19G Flex and 22G standard needles punctures.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbidity
Time Frame: 2 minutes, up to day 30
immediate per-procedure complications and delayed morbidity (up to day 30) side effects resulting of technical failure or dysfunction of the puncture ease of handling for the two needles (visual analogic scale)
2 minutes, up to day 30
quality of histology
Time Frame: 10 days
quality of histological specimens obtained with the 2 types of needles (visual analogic scale)
10 days

Collaborators and Investigators

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

Sponsor

French Society of Digestive Endoscopy

Investigators

  • Principal Investigator: CHRISTIAN BOUSTIERE, MD, FRENCH SDE

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

April 1, 2013

Primary Completion (Actual)

July 6, 2016

Study Completion (Actual)

January 23, 2017

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFED N°98

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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