NCT02922049

Brief Summary

To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

September 23, 2016

Last Update Submit

February 15, 2020

Conditions

Barrett's Esophagus

Keywords

Probe Based Confocal Laser Endomicroscopy (pCLE)Barrett's esophagusBORNIntestinal metaplasia

Outcome Measures

Primary Outcomes (1)

  • Detection of persistent or recurrent intestinal metaplasia/dysplasia and esophageal and gastric lesions by confocal laser endomicroscopy and classic histopathology

    till 3 day after procedure

Secondary Outcomes (1)

  • Sensitivity and specificity of the procedure

    through study completion, an average of 1 year

Study Arms (1)

pCLE vs. biopsies with histopathology

OTHER

The investigators will compare diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients with esophageal and gastric lesions and in patients after completed endoscopic treatment of BORN. All samples taken by biopsies will be correlated with the images taken by pCLE in the detection of lesions, intestinal metaplasia, dysplasia and buried glands.

Other: Biopsies with histopathology

Interventions

Biopsies with histopathologyOTHER

All samples taken by biopsies will be correlated with the images taken by CLE.

pCLE vs. biopsies with histopathology

Eligibility Criteria

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

You may qualify if:

  • age \> 18
  • macroscopic lesion of esophagus or stomach (Project A)
  • pts after ER/ESD/RFA for BORN (Project B)
  • eradication of BORN and Barrett's esophagus macro- and microscopically (Project B)
  • sign agreement with study

You may not qualify if:

  • macroscopic persistence of Barrett's esophagus (e.g. tongues)
  • esophageal varices
  • treatment with anticoagulants
  • allergy to fluorescein
  • polyvalent allergy
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Prague, 14021, Czechia

Location

Related Publications (12)

  • Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.

    PMID: 21741642BACKGROUND

  • Meining A, Shah RJ, Slivka A, Pleskow D, Chuttani R, Stevens PD, Becker V, Chen YK. Classification of probe-based confocal laser endomicroscopy findings in pancreaticobiliary strictures. Endoscopy. 2012 Mar;44(3):251-7. doi: 10.1055/s-0031-1291545. Epub 2012 Jan 19.

    PMID: 22261749BACKGROUND

  • Shahid MW, Buchner AM, Coron E, Woodward TA, Raimondo M, Dekker E, Fockens P, Wallace MB. Diagnostic accuracy of probe-based confocal laser endomicroscopy in detecting residual colorectal neoplasia after EMR: a prospective study. Gastrointest Endosc. 2012 Mar;75(3):525-33. doi: 10.1016/j.gie.2011.08.024. Epub 2011 Nov 1.

    PMID: 22051243BACKGROUND

  • Musquer N, Coquenlorge S, Bourreille A, Aubert P, Matysiak-Budnik T, des Varannes SB, Lauwers G, Neunlist M, Coron E. Probe-based confocal laser endomicroscopy: a new method for quantitative analysis of pit structure in healthy and Crohn's disease patients. Dig Liver Dis. 2013 Jun;45(6):487-92. doi: 10.1016/j.dld.2013.01.018. Epub 2013 Mar 7.

    PMID: 23466186BACKGROUND

  • Mannath J, Subramanian V, Kaye PV, Ragunath K. Life-threatening bleeding following Barrett's surveillance biopsies. Endoscopy. 2010;42 Suppl 2:E211-2. doi: 10.1055/s-0030-1255717. Epub 2010 Sep 15. No abstract available.

    PMID: 20845277BACKGROUND

  • Kopacova M, Bures J, Osterreicher J, Kvetina J, Pejchal J, Tacheci I, Kunes M, Spelda S, Rejchrt S. Confocal laser endomicroscopy in experimental pigs. Methods of ex vivo imaging. Cas Lek Cesk. 2009;148(6):249-53.

    PMID: 19642306BACKGROUND

  • Wang KK, Carr-Locke DL, Singh SK, Neumann H, Bertani H, Galmiche JP, Arsenescu RI, Caillol F, Chang KJ, Chaussade S, Coron E, Costamagna G, Dlugosz A, Ian Gan S, Giovannini M, Gress FG, Haluszka O, Ho KY, Kahaleh M, Konda VJ, Prat F, Shah RJ, Sharma P, Slivka A, Wolfsen HC, Zfass A. Use of probe-based confocal laser endomicroscopy (pCLE) in gastrointestinal applications. A consensus report based on clinical evidence. United European Gastroenterol J. 2015 Jun;3(3):230-54. doi: 10.1177/2050640614566066.

    PMID: 26137298BACKGROUND

  • Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.

    PMID: 22749368BACKGROUND

  • Konda VJ, Meining A, Jamil LH, Giovannini M, Hwang JH, Wallace MB, Chang KJ, Siddiqui UD, Hart J, Lo SK, Saunders MD, Aslanian HR, Wroblewski K, Waxman I. A pilot study of in vivo identification of pancreatic cystic neoplasms with needle-based confocal laser endomicroscopy under endosonographic guidance. Endoscopy. 2013 Dec;45(12):1006-13. doi: 10.1055/s-0033-1344714. Epub 2013 Oct 25.

    PMID: 24163192BACKGROUND

  • Siddiqui AA, Shahid H, Shah A, Khurana T, Huntington W, Ghumman SS, Loren DE, Kowalski TE, Laique S, Hayat U, Eloubeidi MA. High risk of acute pancreatitis after endoscopic ultrasound-guided fine needle aspiration of side branch intraductal papillary mucinous neoplasms. Endosc Ultrasound. 2015 Apr-Jun;4(2):109-14. doi: 10.4103/2303-9027.156728.

    PMID: 26020044BACKGROUND

  • Napoleon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Filoche B, Giovannini M. A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy. Endoscopy. 2015 Jan;47(1):26-32. doi: 10.1055/s-0034-1390693. Epub 2014 Oct 17.

    PMID: 25325684BACKGROUND

  • Kollar M, Krajciova J, Prefertusova L, Sticova E, Maluskova J, Vackova Z, Martinek J. Probe-based confocal laser endomicroscopy versus biopsies in the diagnostics of oesophageal and gastric lesions: A prospective, pathologist-blinded study. United European Gastroenterol J. 2020 May;8(4):436-443. doi: 10.1177/2050640620904865. Epub 2020 Jan 28.

    PMID: 32213027DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jan Martinek, MD. PhD.

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. MD. Ph.D. AGAF

Study Record Dates

First Submitted

September 23, 2016

First Posted

October 3, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

January 1, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Locations

CZ(1)