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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01479803
Other study ID # 2011-A00578-33
Secondary ID
Status Completed
Phase Phase 3
First received October 20, 2011
Last updated April 22, 2014
Start date October 2011
Est. completion date October 2012

Study information

Verified date April 2014
Source Société Française d'Endoscopie Digestive
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic


Intervention

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

Locations

Country Name City State
France Hôpital L'Archet 2, CHU Nice, BP 3079 Nice Cedex 3

Sponsors (1)

Lead Sponsor Collaborator
VANBIERVLIET

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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). 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 Yes
Secondary Quality of histological specimen obtained with the 2 needles Visual analogic scale and Maier score used for this point 10 days No
Secondary Dysfunction in two type of needle biopsy failure or difficulty reports with each needle (%) Day one Yes
Secondary ease of puncture between the 2 types of equipment. Visual analogic scale day one No
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