EUS GUIDED Transduodenal Biopsy Using the 19G Flex (NIFLEX)
Abdominal Neoplasms
About this trial
This is an interventional diagnostic trial for Abdominal Neoplasms focused on measuring EUS-guided biopsy, EUS-FNB
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- Indiana Univerisity Health Medical Center
- Clinique du Trocadero
- AUSL Bologna Bellaria-Maggiore Hospital
- ISMETT UPMC Italy
- Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore
- Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology
Arms of the Study
Arm 1
Experimental
patients with solid lesions
Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)