NCT02246322

Brief Summary

Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle. The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

September 1, 2014

Last Update Submit

September 18, 2014

Conditions

Pancreatic CancerNeuroendocrine TumorsLymphadenopathiesGISTGastric Wall Tumor

Keywords

Pancreatic cancerNeuroendocrine tumorsLymphadenopathiesGISTGastrointestinal wall neoplasia

Outcome Measures

Primary Outcomes (1)

  • Clinical performance of 22G and 25G needles

    Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.

    18 months

Secondary Outcomes (5)

  • Ease of needle pass

    18 months

  • Needle malfunction

    18 months

  • Number of passes

    18 months

  • Number of crossovers

    18 months

  • Major complications

    18 months

Study Arms (2)

25G needle

EXPERIMENTAL

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

Device: 25G needle

22G needle

EXPERIMENTAL

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

Device: 22G needle

Interventions

25G needleDEVICE

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

25G needle
22G needleDEVICE

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

22G needle

Eligibility Criteria

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

You may qualify if:

  • endosonographic appearance of a solid lesions
  • age \>18 years
  • informed consent.

You may not qualify if:

  • alteration of the coagulation (INR \>1.5, PLT \<50 x 103 /µL)
  • inability to express consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (2)

  • Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.

    PMID: 21611946BACKGROUND

  • Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.

    PMID: 19640524BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsNeuroendocrine TumorsLymphadenopathy

Interventions

Needles

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Silvia Carrara, MD

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Carrara, MD

CONTACT

+390282247288silvia.carrara@humanitas.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 22, 2014

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations

IT(1)