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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 (PatheBarett)

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ClinicalTrials.gov Identifier: NCT03685799
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Barretts Esophagus With Dysplasia Diagnostic Test: Pathological revision

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.

Study Design
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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : May 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy

Groups and Cohorts
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Group/Cohort Intervention/treatment
DHG on Barrett's esophagus
patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection
 Diagnostic Test: Pathological revision
Pathological revision


Outcome Measures
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Primary Outcome Measures :
  1. Influence of histological concordance on the risk of recurrence [ Time Frame: 1 day ]
    the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.


Secondary Outcome Measures :
  1. Identification of histological factors of recurrence. [ Time Frame: 1 day ]
    Identification of histological factors of recurrence.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685799


Locations
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France
Institut Paoli-Calmettes
Marseille, Bouches-du Rhône, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
More Information
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Publications of Results:

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03685799    
Other Study ID Numbers: PatheBarett-IPC 2016-005
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
Barretts Esophagus
Dysplasia
Additional relevant MeSH terms:
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Barrett Esophagus
Recurrence
Hyperplasia
Disease Attributes
Pathologic Processes
 Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases