NCT01016288

Brief Summary

The aim of the study is to compare the performance characteristics of EUS-FNA 22 Gauge needle and EUS FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of various pathologies, including lymph nodes, pancreatic, luminal and other lesions outlined by EUS.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
3 countries

9 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

November 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

5 months

First QC Date

November 18, 2009

Last Update Submit

April 7, 2014

Conditions

Mediastinal Tumours and Lymph NodesCeliac, Perigastric and Peri-pancreatic Lymph NodesPancreatic MassesLiver MassesAdrenal Masses

Keywords

EUS-FNA22 Gauge Needle25 Gauge Needle

Outcome Measures

Primary Outcomes (1)

  • Value of EUS-FNA 22 Gauge needle comparing with EUS-FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of various pathologies.

    6 months

Study Arms (2)

22 G Needle EUS-FNA

Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 22 G needle

25 G Needle EUS-FNA

Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 25 G needle

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to one of the participating departments for an EUS examination with EUS-FNA (mediastinal tumours and lymph nodes, celiac, perigastric and peri-pancreatic lymph nodes, pancreatic masses, liver masses, adrenal masses, etc.).

You may qualify if:

  • Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract
  • Well informed signed consent for EUS-guided FNA

You may not qualify if:

  • Severe coagulopathy
  • Uncorrectable severe platelet dysfunction
  • Presence of large intervening vessels on color or power Doppler
  • Failure to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Department of Pathology, Herlev University Hospital, Hellerup

Copenhagen, Denmark

Location

Endoscopy Z-806, Gentofte, Department of Surgical Gastroenterology, Gentofte and Herlev Hospitals

Copenhagen, Denmark

Location

Department of Medicine, GI Division, Allgemeines Krankenhaus MD

Celle, Germany

Location

Klinik für Gastroenterologie/GI-Onkologie, Allgemeines Krankenhaus Celle

Celle, Germany

Location

Pathologic Institute, Wittinger Strasse

Celle, Germany

Location

Cytological Laboratory, Hospital Grosshansdorf - Center for Pneumology and Thoracic Surgery

Großhansdorf, Germany

Location

Department of Internal Medicine, Sana Hospital Lübeck GmbHg, MD

Lübeck, Germany

Location

Department of Pathology, Medical University Schleswig-Holstein

Lübeck, Germany

Location

Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy

Craiova, Romania

Location

Related Publications (3)

  • Vilmann P, Puri R. The complete ''medical'' mediastinoscopy (EUS-FNA + EBUS-TBNA). Minerva Med. 2007 Aug;98(4):331-8.

    PMID: 17921946BACKGROUND

  • Saftoiu A, Vilmann P, Guldhammer Skov B, Georgescu CV. Endoscopic ultrasound (EUS)-guided Trucut biopsy adds significant information to EUS-guided fine-needle aspiration in selected patients: a prospective study. Scand J Gastroenterol. 2007 Jan;42(1):117-25. doi: 10.1080/00365520600789800.

    PMID: 17190771BACKGROUND

  • Vilmann P, Saftoiu A, Hollerbach S, Skov BG, Linnemann D, Popescu CF, Wellmann A, Gorunescu F, Clementsen P, Freund U, Flemming P, Hassan H, Gheonea DI, Streba L, Ioncica AM, Streba CT. Multicenter randomized controlled trial comparing the performance of 22 gauge versus 25 gauge EUS-FNA needles in solid masses. Scand J Gastroenterol. 2013 Jul;48(7):877-83. doi: 10.3109/00365521.2013.799222.

    PMID: 23795663DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Pathology samples obtained through EUS-FNA biopsy processed by paraffin embedding.

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Peter Vilmann, Professor

    Gentofte Hospital, Copenhagen University, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

December 1, 2012

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

DE(6)RO(1)DK(2)