EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Completed · Not applicable

Conditions studied: Abdominal Neoplasms

In brief

This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.

Key facts

Study ID

NCT02307253

Run by

Catholic University of the Sacred Heart

People needed

246

Starts

2013-06-01

Expected to finish

2015-10-01

Last updated by the study team

2022-06-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A. Age greater than 18 and less than 90. B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis.
• C. Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
• D. Informed consent is obtained.

You may not qualify if…

• A. Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
• B. Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
• C. They are unable to understand and/or read the consent form.

Where it is running

• Indiana Univerisity Health Medical Center — Indianapolis, Indiana, United States
• Clinique du Trocadero — Paris, France
• AUSL Bologna Bellaria-Maggiore Hospital — Bologna, Italy
• ISMETT UPMC Italy — Palermo, Italy
• Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore — Rome, Italy
• Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology — Kawasaki, Kanagawa, Japan

Full record on ClinicalTrials.gov

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