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

NCT01479803 | Completed Phase 3 DMC

• 1 other identifier: 2011-A00578-33
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Tumor; Fine Needle Aspiration; Endoscopic Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• 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).

  2 minutes and 30 days

• Quality of histological specimen obtained with the 2 needles

  10 days

• Dysfunction in two type of needle biopsy

  Day one

• ease of puncture between the 2 types of equipment.

  day one

Study Arms (2)

EchoTip HD ProCore 22 Gauge

ACTIVE COMPARATOR

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

Echo Tip 22 Gauge

ACTIVE COMPARATOR

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

Interventions

Puncture with fine needle aspiration under endoscopic ultrasonographic control PROCEDURE

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

Echo Tip 22 Gauge; EchoTip HD ProCore 22 Gauge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VANBIERVLIET: lead

Study Sites (1)

Hôpital L'Archet 2, CHU Nice, BP 3079

Nice, 06202, France

Location

Related Publications (1)

• Vanbiervliet G, Napoleon B, Saint Paul MC, Sakarovitch C, Wangermez M, Bichard P, Subtil C, Koch S, Grandval P, Gincul R, Karsenti D, Heyries L, Duchmann JC, Bourgaux JF, Levy M, Calament G, Fumex F, Pujol B, Lefort C, Poincloux L, Pagenault M, Bonin EA, Fabre M, Barthet M. Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study. Endoscopy. 2014 Dec;46(12):1063-70. doi: 10.1055/s-0034-1377559. Epub 2014 Aug 6.

  PMID: 25098612 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Punctures

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of endoscopy, Principal Investigator, Medical doctor

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: November 24, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

FR (1)