Status:

UNKNOWN

EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors

Lead Sponsor:

Istituto Clinico Humanitas

Conditions:

Gastrointestinal Subepithelial Tumors

Eligibility:

All Genders

18-85 years

Brief Summary

The differentiation among the Gastrointestinal Subepithelial Tumors (SETs) represents a clinical challenge. Endoscopic Ultrasound (EUS) alone may be ineffective in differentiating SETs subtypes, and t...

Eligibility Criteria

Inclusion

  • Patients with GI SETs scheduled for EUS-FNB
  • Patients with age \> 18 but \<85 years

Exclusion

  • Patients with GI SETs \<15mm
  • severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
  • severe cardiopulmonary diseases and severe chronic kidney disease defined as glomerular filtration rate (GFR) \< 15 ml/min
  • known allergic disposition to SonoVue®
  • pregnancy

Key Trial Info

Start Date :

January 27 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04695262

Start Date

January 27 2021

End Date

December 31 2023

Last Update

March 21 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, Italy, 20089