NCT02583087

Brief Summary

This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

3.2 years

First QC Date

October 20, 2015

Last Update Submit

August 25, 2017

Conditions

Barrett EsophagusEsophageal Neoplasm

Keywords

Barrett esophagusEsophageal adenocarcinomaEndoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

  • Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia

    R0 resection rate = horizontal margins free from cancer or high grade dysplasia, and vertical margins free from carcinoma.

    3 months after ESD initial procedure

Secondary Outcomes (7)

  • Rate of en bloc resection via ESD

    3 months after ESD initial procedure

  • Rate of histologically complete (R0) resection of esophageal adenocarcinoma

    3 months after ESD initial procedure

  • Rate of histologically complete (R0) resection of low grade dysplasia

    3 months after ESD initial procedure

  • Curative resection rate of adenocarcinoma

    3 months after ESD initial procedure

  • Complication rates

    3 months

  • +2 more secondary outcomes

Interventions

endoscopic submucosal dissectionPROCEDURE

Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.

Also known as: endoscopic resection, ESD

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18 to 90 years old with a visible lesion suspected of adenocarcinoma arising in a Barrett's esophagus amenable to resection by ESD.

You may qualify if:

  • Barrett's esophagus at least C0M2 with histological documentation of intestinal metaplasia
  • Visible abnormality of at least 15 mm in size
  • Absence of mediastinal or coeliomesenteric enlarged lymph nodes or muscle layer invasion on pretherapeutic EUS
  • Absence of mediastinal or coeliomesenteric enlarged lymph nodes or metastases on pretherapeutic CT scan

You may not qualify if:

  • History of esophageal external irradiation
  • History of esophagectomy or gastrectomy gastrectomie ou d'oesophagectomie
  • Esophageal stricture
  • Esophageal varices grade 3 or of any grade with signs of recent bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Barrett EsophagusEsophageal NeoplasmsAdenocarcinoma Of Esophagus

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Frederic Prat, MD, PhD

CONTACT

00331 58 41 19 85frederic.prat@aphp.fr

Maximilien Barret, Md, PhD

CONTACT

00331 58 41 42 85maximilien.barret@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Frederic Prat

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 21, 2015

Study Start

January 2, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2022

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

FR(1)