NCT02307253

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

June 27, 2022

Completed
Last Updated

June 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.3 years

First QC Date

November 19, 2014

Results QC Date

May 30, 2022

Last Update Submit

May 30, 2022

Conditions

Abdominal Neoplasms

Keywords

EUS-guided biopsy, EUS-FNB

Outcome Measures

Primary Outcomes (1)

  • 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

    Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients.

    Intraoperative

Secondary Outcomes (3)

  • Number of Complications Divided Per Total Number of Enrolled Patients

    intraoperative and within 3 days after the procedure

  • Number of Histological Samples Judged Adequate Divided by the Total Number of Patients

    5 days

  • Number of Correct Diagnosis Divided by the Total Number of Patients

    6 months

Study Arms (1)

patients with solid lesions

EXPERIMENTAL

Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)

Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)

Interventions

Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)DEVICE

EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle

patients with solid lesions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Indiana Univerisity Health Medical Center

Indianapolis, Indiana, 46202, United States

Location

Clinique du Trocadero

Paris, France

Location

AUSL Bologna Bellaria-Maggiore Hospital

Bologna, 40139, Italy

Location

ISMETT UPMC Italy

Palermo, 90100, Italy

Location

Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology

Kawasaki, Kanagawa, 213-8507, Japan

Location

Related Publications (1)

  • Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc. 2012 Aug;76(2):336-43. doi: 10.1016/j.gie.2012.04.455.

    PMID: 22817786RESULT

MeSH Terms

Conditions

Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Results Point of Contact

Title
Dr Alberto Larghi
Organization
Fondazione Policlino Universitario A Gemelli IRCCS
alberto.larghi@yahoo.it
0630156580

Study Officials

  • Guido Costamagna, MD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 4, 2014

Study Start

June 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 27, 2022

Results First Posted

June 27, 2022

Record last verified: 2022-05

Locations

FR(1)JP(1)US(1)IT(3)