NCT03191604

Brief Summary

This study tests the impact of narrow band imaging (NBI) on endoscopists' accurate detection of visible lesions and dysplasia in patients with Barrett's esophagus, as well as the effect of NBI on the choice of primary treatment modality among endoscopists performing endoscopic eradication therapy (EET).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

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

First Submitted

Initial submission to the registry

June 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

November 4, 2019

Status Verified

November 1, 2019

Enrollment Period

1.5 years

First QC Date

June 15, 2017

Last Update Submit

November 1, 2019

Conditions

Barrett Esophagus

Keywords

EndoscopyNarrow band imagingDysplasia

Outcome Measures

Primary Outcomes (1)

  • Altered chosen treatment modality due to NBI

    Percentage of cases in which use of NBI altered decision-making in regards to initial treatment modality for patients undergoing EET.

    1 year

Secondary Outcomes (3)

  • % visable dysplastic lesions detected

    1 year

  • Accurate pathology assessment

    1 year

  • Differences in pathology identification between subgroups

    1 year

Study Arms (1)

Endoscopists familiar with EET

Physicians familiar with conducting endoscopic eradication therapy.

Other: Video intervention

Interventions

Video interventionOTHER

Video clips of endoscopy footage with just HD-WLE and clips with NBI will be shown to endoscopists.

Endoscopists familiar with EET

Eligibility Criteria

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

Endoscopist sub-groups include academic endoscopists performing greater than 50 EET procedures per year, community endoscopists performing greater than 50 EET procedures per year, 25 academic gastroenterologists performing greater than 500 upper endoscopies per year not including EET, and 25 community gastroenterologists performing greater than 500 upper endoscopies per year not including EET.

You may qualify if:

  • Endoscopists familiar with EET.

You may not qualify if:

  • Endoscopists not familiar with EET or non-endoscopists.
  • Special populations will not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (18)

  • Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.

    PMID: 25162890BACKGROUND

  • Hayeck TJ, Kong CY, Spechler SJ, Gazelle GS, Hur C. The prevalence of Barrett's esophagus in the US: estimates from a simulation model confirmed by SEER data. Dis Esophagus. 2010 Aug;23(6):451-7. doi: 10.1111/j.1442-2050.2010.01054.x. Epub 2010 Mar 26.

    PMID: 20353441BACKGROUND

  • Ireland CJ, Thompson SK, Laws TA, Esterman A. Risk factors for Barrett's esophagus: a scoping review. Cancer Causes Control. 2016 Mar;27(3):301-23. doi: 10.1007/s10552-015-0710-5. Epub 2016 Feb 5.

    PMID: 26847374BACKGROUND

  • Shaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3.

    PMID: 26526079BACKGROUND

  • Incarbone R, Bonavina L, Saino G, Bona D, Peracchia A. Outcome of esophageal adenocarcinoma detected during endoscopic biopsy surveillance for Barrett's esophagus. Surg Endosc. 2002 Feb;16(2):263-6. doi: 10.1007/s00464-001-8161-3. Epub 2001 Nov 16.

    PMID: 11967675BACKGROUND

  • Ferguson MK, Durkin A. Long-term survival after esophagectomy for Barrett's adenocarcinoma in endoscopically surveyed and nonsurveyed patients. J Gastrointest Surg. 2002 Jan-Feb;6(1):29-35; discussion 36. doi: 10.1016/s1091-255x(01)00052-x.

    PMID: 11986015BACKGROUND

  • Fountoulakis A, Zafirellis KD, Dolan K, Dexter SP, Martin IG, Sue-Ling HM. Effect of surveillance of Barrett's oesophagus on the clinical outcome of oesophageal cancer. Br J Surg. 2004 Aug;91(8):997-1003. doi: 10.1002/bjs.4591.

    PMID: 15286961BACKGROUND

  • van Sandick JW, van Lanschot JJ, Kuiken BW, Tytgat GN, Offerhaus GJ, Obertop H. Impact of endoscopic biopsy surveillance of Barrett's oesophagus on pathological stage and clinical outcome of Barrett's carcinoma. Gut. 1998 Aug;43(2):216-22. doi: 10.1136/gut.43.2.216.

    PMID: 10189847BACKGROUND

  • Fitzgerald RC, Saeed IT, Khoo D, Farthing MJ, Burnham WR. Rigorous surveillance protocol increases detection of curable cancers associated with Barrett's esophagus. Dig Dis Sci. 2001 Sep;46(9):1892-8. doi: 10.1023/a:1010678913481.

    PMID: 11575441BACKGROUND

  • Abela JE, Going JJ, Mackenzie JF, McKernan M, O'Mahoney S, Stuart RC. Systematic four-quadrant biopsy detects Barrett's dysplasia in more patients than nonsystematic biopsy. Am J Gastroenterol. 2008 Apr;103(4):850-5. doi: 10.1111/j.1572-0241.2007.01746.x. Epub 2008 Mar 26.

    PMID: 18371135BACKGROUND

  • Sami SS, Subramanian V, Butt WM, Bejkar G, Coleman J, Mannath J, Ragunath K. High definition versus standard definition white light endoscopy for detecting dysplasia in patients with Barrett's esophagus. Dis Esophagus. 2015 Nov-Dec;28(8):742-9. doi: 10.1111/dote.12283. Epub 2014 Sep 10.

    PMID: 25209721BACKGROUND

  • Song J, Zhang J, Wang J, Guo X, Yu S, Wang J, Liu Y, Dong W. Meta-analysis of the effects of endoscopy with narrow band imaging in detecting dysplasia in Barrett's esophagus. Dis Esophagus. 2015 Aug-Sep;28(6):560-6. doi: 10.1111/dote.12222. Epub 2014 Apr 24.

    PMID: 24758693BACKGROUND

  • Jayasekera C, Taylor AC, Desmond PV, Macrae F, Williams R. Added value of narrow band imaging and confocal laser endomicroscopy in detecting Barrett's esophagus neoplasia. Endoscopy. 2012 Dec;44(12):1089-95. doi: 10.1055/s-0032-1325734. Epub 2012 Nov 27.

    PMID: 23188660BACKGROUND

  • Singh M, Gupta N, Gaddam S, Balasubramanian G, Wani S, Sinh P, Aghaie K, Higbee AD, Rastogi A, Kanakadandi V, Bansal A, Sharma P. Practice patterns among U.S. gastroenterologists regarding endoscopic management of Barrett's esophagus. Gastrointest Endosc. 2013 Nov;78(5):689-95. doi: 10.1016/j.gie.2013.05.002. Epub 2013 Jun 14.

    PMID: 23769458BACKGROUND

  • Sharma P, Bergman JJ, Goda K, Kato M, Messmann H, Alsop BR, Gupta N, Vennalaganti P, Hall M, Konda V, Koons A, Penner O, Goldblum JR, Waxman I. Development and Validation of a Classification System to Identify High-Grade Dysplasia and Esophageal Adenocarcinoma in Barrett's Esophagus Using Narrow-Band Imaging. Gastroenterology. 2016 Mar;150(3):591-8. doi: 10.1053/j.gastro.2015.11.037. Epub 2015 Nov 25.

    PMID: 26627609BACKGROUND

  • Sharma P, Hawes RH, Bansal A, Gupta N, Curvers W, Rastogi A, Singh M, Hall M, Mathur SC, Wani SB, Hoffman B, Gaddam S, Fockens P, Bergman JJ. Standard endoscopy with random biopsies versus narrow band imaging targeted biopsies in Barrett's oesophagus: a prospective, international, randomised controlled trial. Gut. 2013 Jan;62(1):15-21. doi: 10.1136/gutjnl-2011-300962. Epub 2012 Feb 7.

    PMID: 22315471BACKGROUND

  • Scholvinck DW, van der Meulen K, Bergman JJGHM, Weusten BLAM. Detection of lesions in dysplastic Barrett's esophagus by community and expert endoscopists. Endoscopy. 2017 Feb;49(2):113-120. doi: 10.1055/s-0042-118312. Epub 2016 Nov 17.

    PMID: 27855466BACKGROUND

  • Singh R, Jayanna M, Wong J, Lim LG, Zhang J, Lv J, Liu D, Lee YC, Han ML, Tseng PH, Namasivayam V, Banerjee R, Uedo N, Chan WK, Ho SH, Chen SY, Bhatia S, Funasaka K, Ando T, Wu J, Lesmana C, Tam W, Wang WL, Chang CY, Jung HY, Jung KW, Bestari MB, Yao K, Chong VH, Sharma P, Ho KY. Narrow-band imaging and white-light endoscopy with optical magnification in the diagnosis of dysplasia in Barrett's esophagus: results of the Asia-Pacific Barrett's Consortium. Endosc Int Open. 2015 Feb;3(1):E14-8. doi: 10.1055/s-0034-1377610. Epub 2014 Sep 26.

    PMID: 26134765BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endoscopy

Study Record Dates

First Submitted

June 15, 2017

First Posted

June 19, 2017

Study Start

November 1, 2017

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

November 4, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)