Barrett Esophagus, Esophageal Neoplasm
Conditions
Keywords
Barrett esophagus, Esophageal adenocarcinoma, Endoscopic submucosal dissection
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.
Detailed description
Endoscopic submucosal dissection ( ESD) demonstrated great efficacy in the treatment of squamous cell carcinoma of the esophagus. Results for the treatment of esophageal adenocarcinoma arising in Barrett's esophagus are conflicting. 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.
Interventions
PROCEDUREendoscopic submucosal dissection
Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.
Sponsors
French Society of Digestive Endoscopy
European Georges Pompidou Hospital
Hôpital Edouard Herriot
Hospital Prive Jean Mermoz
University Hospital, Limoges
University Hospital, Bordeaux
Centre Hospitalier Universitaire de Nice
Hôpital Cochin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia | 3 months after ESD initial procedure | R0 resection rate = horizontal margins free from cancer or high grade dysplasia, and vertical margins free from carcinoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of histologically complete (R0) resection of esophageal adenocarcinoma | 3 months after ESD initial procedure | R0 resection rate = horizontal margins free from cancer, and vertical margins free from carcinoma. |
| Rate of histologically complete (R0) resection of low grade dysplasia | 3 months after ESD initial procedure | R0 resection rate = horizontal margins free from cancer, high or low grade dysplasia, and vertical margins free from carcinoma. |
| Curative resection rate of adenocarcinoma | 3 months after ESD initial procedure | R0 resection of adenocarcinoma, with submucosal invasion \<500micrometers, absence of poor differenciation or lymphovascular invasion |
| Rate of en bloc resection via ESD | 3 months after ESD initial procedure | presence of a single fragment of tissue on histopathological analysis |
| rate of complete remission of adenocarcinoma, high grade dysplasia, low grade dysplasia, and intestinal metaplasia at 1 and 3 years | 3 years after initial procedure | rate of normal endoscopic and histologic follow-up after ESD |
| rate of buried glands | 3 years | Presence of Buried glands on histological analysis of follow-up biopsies |
| Complication rates | 3 months | early or late complications of ESD |
Countries
France
Contacts
Primary ContactFrederic Prat, MD, PhD
Backup ContactMaximilien Barret, Md, PhD
Outcome results
None listed