Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2016-01-02
2022-04-30
Brief Summary
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Detailed Description
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In this multicenter prospective registry among 7 French centers, all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection will be included in the registry. The primary objective is to assess the quality of the resection by ESD of early Barrett's neoplasia (T1A or T1B sm1 or high grade dysplasia). Secondary endpoints are to assess the combined efficacy of a treatment associating ESD and radiofrequency ablation of the remaining Barrett esophagus, and to assess the durability of the results after 3 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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endoscopic submucosal dissection
Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of esophagectomy or gastrectomy gastrectomie ou d'oesophagectomie
* Esophageal stricture
* Esophageal varices grade 3 or of any grade with signs of recent bleeding
18 Years
90 Years
ALL
No
Sponsors
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French Society of Digestive Endoscopy
OTHER
European Georges Pompidou Hospital
OTHER
Hôpital Edouard Herriot
OTHER
Hospital Prive Jean Mermoz
OTHER
University Hospital, Limoges
OTHER
University Hospital, Bordeaux
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
Hôpital Cochin
OTHER
Responsible Party
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Frederic PRAT
Professor Frederic Prat
Locations
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Cochin Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20102015
Identifier Type: -
Identifier Source: org_study_id
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