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

This study is currently recruiting participants.
Verified October 2011 by Société Française d'Endoscopie Digestive
Sponsor:
Information provided by (Responsible Party):
VANBIERVLIET, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier:
NCT01479803
First received: October 20, 2011
Last updated: November 22, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Tumor
Fine Needle Aspiration
Endoscopic Ultrasonography
 Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Société Française d'Endoscopie Digestive:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Adverse effects (%, number of event for each needle passage) during the procedure or during the follow up period (30 days)

  • Quality of histological specimen obtained with the 2 needles [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Visual analogic scale and Maier score used for this point

  • Dysfunction in two type of needle biopsy [ Time Frame: Day one ] [ Designated as safety issue: Yes ]
    failure or difficulty reports with each needle (%)

  • ease of puncture between the 2 types of equipment. [ Time Frame: day one ] [ Designated as safety issue: No ]
    Visual analogic scale


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479803

Contacts
Contact: Geoffroy VANBIERVLIET, MD +33 (0)4 92 03 63 85 vanbiervliet.g@chu-nice.fr

Locations
France
Hôpital L'Archet 2, CHU Nice, BP 3079 Recruiting
Nice Cedex 3, France, 06202
Contact: Geoffroy Vanbiervliet, MD     +33 (0)492036385     vanbiervliet.g@chu-nice.fr    
Principal Investigator: Geoffroy Vanbiervliet, MD            
Sponsors and Collaborators
VANBIERVLIET
  More Information

No publications provided

Responsible Party: VANBIERVLIET, Director, Head of endoscopy, Principal Investigator, Medical doctor, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier: NCT01479803     History of Changes
Other Study ID Numbers: 2011-A00578-33
Study First Received: October 20, 2011
Last Updated: November 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013