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

VANBIERVLIET

Status and phase

Completed

Phase 3

Conditions

Fine Needle Aspiration

Endoscopic Ultrasonography

Pancreatic Tumor

Treatments

Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control

Study type

Interventional

Funder types

Other

Identifiers

NCT01479803

2011-A00578-33

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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