Status:
COMPLETED
EUS GUIDED Transduodenal Biopsy Using the 19G Flex
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Abdominal Neoplasms
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 sam...
Detailed Description
A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided procedure. The use of nitinol should guarantee a better needle flexibility with a theoretical advantage on...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT02307253
Start Date
June 1 2013
End Date
October 1 2015
Last Update
June 27 2022
Active Locations (6)
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1
Indiana Univerisity Health Medical Center
Indianapolis, Indiana, United States, 46202
2
Clinique du Trocadero
Paris, France
3
AUSL Bologna Bellaria-Maggiore Hospital
Bologna, Italy, 40139
4
ISMETT UPMC Italy
Palermo, Italy, 90100