Contrast-harmonic Endoscopic Ultrasound (CH-EUS) for the Diagnosis of Pancreatic Adenocarcinoma

NCT01765036 | Completed DMC

• 1 other identifier: 2008-004676-44
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Ductal adenocarcinoma is the most frequent pancreatic solid lesion and the most common tumor of the pancreas. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory. EUS is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors \[1-3\]. Nevertheless it remains difficult to differentiate, on morphological features, PA from other solid masses. For 15 years, endoscopic ultrasound fine needle aspiration (EUS-FNA) has demonstrated its efficiency for tissue sampling and cyto-histologic diagnosis of PA. However, the negative predictive value (NPV) for the diagnosis of pancreatic adenocarcinoma (PA) remains low (30-70%) in the published prospective series \[4\]. So, in case of negative result, the choice between surgery and follow-up remains difficult. Additional criteria to get the decision are then warranted. The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in real time with imaging specific methods seems useful to improve their characterization \[4-8\] either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-enhanced harmonic EUS (CH-EUS). The aims of this prospective multicenter study is:

1. 1.to compare the NPV of contrast-enhanced endoscopic ultrasound (CH-EUS) and EUS-FNA for the diagnosis of PA;
2. 2.to assess the intra- and inter-observer concordances of CH-EUS for the diagnosis of PA.

Conditions

Pancreatic Adenocarcinoma

Keywords

contrast-enhanced endoscopic ultrasound; pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• negative predictive value (NPV) of contrast-enhanced endoscopic ultrasound (CH-EUS) for the diagnosis of pancreatic adenocarcinoma (PA)

  To evaluate the NPV of CH-EUS for the diagnosis of PA to EUS-FNA and final diagnosis

  one year

Secondary Outcomes (7)

• to asses intra-observer concordances of CH-EUS for the diagnosis of PA

  two days

• to asses inter-observer concordances of CH-EUS for the diagnosis of PA

  two days

• sensibility (Se) of contrast-enhanced endoscopic ultrasound (CH-EUS) for the diagnosis of pancreatic adenocarcinoma (PA)

  one year

• Specificity (Spe) of CH-EUS for the diagnosis of pancreatic adenocarcinoma (PA)

  one year

• Positive predictive value (PPV) of CH-EUS for diagnosis of pancreatic adenocarcinoma (PA)

  one year

Study Arms (1)

SonoVue®

EXPERIMENTAL

Non randomised study Sonovue 4,8 ml intravenous administration, in 1 bolus, during the EUS examination

Drug: SonoVue®

Interventions

SonoVue® DRUG

An intravenous 4.8 ml SonoVue® bolus injection was administered to each patient during the procedure

Also known as: soufre hexafluorure

SonoVue®

Eligibility Criteria

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

You may qualify if:

• patients with a solid pancreatic mass of indeterminate origin

You may not qualify if:

• presence of a cystic component greater than 25 % of the total volume of the lesion, pregnancy, lactation, age \<18 years, and usual contraindications to SonoVue® injection

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Société Française d'Endoscopie Digrestive

Paris, 75006, France

Location

MeSH Terms

Interventions

contrast agent BR1

Study Officials

• Rodica Gincul, MD

  Société Française d'Endoscopie Digestive

  PRINCIPAL INVESTIGATOR

• Bertrand Napoleon, MD

  Société Française d'Endoscopie Digestive

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 10, 2013
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

FR (1)