N/A N=246 Diagnostic

EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Abdominal Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT02307253 ↗

Enrolled (actual)

246

Serious AEs

2.4%

Results posted

Jun 2022

Primary outcome: Primary: Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion — 228 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Catholic University of the Sacred Heart
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion	228	—
SECONDARY Number of Complications Divided Per Total Number of Enrolled Patients	6	—
SECONDARY Number of Histological Samples Judged Adequate Divided by the Total Number of Patients	189	—
SECONDARY Number of Correct Diagnosis Divided by the Total Number of Patients	181	—

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 samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02307253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.