Status:
COMPLETED
22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborating Sponsors:
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Conditions:
Abdominal Neoplasms
Eligibility:
All Genders
10-80 years
Phase:
NA
Brief Summary
To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.
Detailed Description
The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Proco...
Eligibility Criteria
Inclusion
- Age greater than 18 and less than 80.
- Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- 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.
- Informed consent is obtained
Exclusion
- Previous biopsy of the lesion with diagnosis of malignancy
- 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.
- They are unable to understand and/or read the consent form.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04032951
Start Date
September 1 2014
End Date
September 1 2015
Last Update
July 25 2019
Active Locations (2)
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1
ISMETT
Palermo, Italy
2
Universita cattolica del sacro cuore
Rome, Italy