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CompletedNCT03685799PatheBarettUpdated Dec 14, 2018

Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia

An observational study in Barretts Esophagus With Dysplasia, sponsored by Institut Paoli-Calmettes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-14.

Sponsored by Institut Paoli-Calmettes · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study summary

Influence of histological concordance on the risk of recurrence:

the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

Read the detailed description

Influence of histological concordance on the risk of recurrence:

the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

02

Conditions studied

  • Barretts Esophagus With Dysplasia

Keywords

  • Barretts Esophagus
  • Dysplasia
03

In context

Barrett Esophagus

310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.

This study's enrollment of 18 is below the median of 127 across 115 observational studies indexed under Barrett Esophagus.

Browse Barrett Esophagus studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.

Inclusion criteria

  • patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • DHG on Barrett's esophagus

    patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection

    Diagnostic Test: Pathological revision

Interventions

  • Diagnostic testPathological revision

    Pathological revision

06

What researchers measure

Primary outcomes

  1. Influence of histological concordance on the risk of recurrence

    the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

    Time frame: 1 day

Secondary outcomes

  1. Identification of histological factors of recurrence.

    Identification of histological factors of recurrence.

    Time frame: 1 day

07

Study locations

1 site
  • Institut Paoli-Calmettes
    Marseille, Bouches-du Rhône 13009, France
08

References and documents

Publications

  • Godat S, Caillol F, Autret A, Bories E, Pesenti C, Ratone JP, De Cassan C, Poizat F, Giovannini M. Endotherapy in case of relapse of neoplastic Barrett's esophagus after successful initial endoscopic resection. Surg Endosc. 2017 Sep;31(9):3703-3710. doi: 10.1007/s00464-016-5409-5. Epub 2017 Jan 11. PubMed 28078459 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03685799
Lead sponsor
Institut Paoli-Calmettes
Responsible party
Sponsor
First posted
Sep 26, 2018
Start date
May 2016
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Dec 14, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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