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| Name | Class |
|---|---|
| French Society of Digestive Endoscopy | OTHER |
| European Georges Pompidou Hospital | OTHER |
| Hôpital Edouard Herriot | OTHER |
| Hospital Prive Jean Mermoz |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic submucosal dissection | Procedure | Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of en bloc resection via ESD | presence of a single fragment of tissue on histopathological analysis | 3 months after ESD initial procedure |
| Rate of histologically complete (R0) resection of esophageal adenocarcinoma |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederic Prat, MD, PhD | Contact | 00331 58 41 19 85 | frederic.prat@aphp.fr | |
| Maximilien Barret, Md, PhD | Contact | 00331 58 41 42 85 | maximilien.barret@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Recruiting | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| OTHER |
| University Hospital, Limoges | OTHER |
| University Hospital, Bordeaux | OTHER |
| Centre Hospitalier Universitaire de Nice | OTHER |
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R0 resection rate = horizontal margins free from cancer, and vertical margins free from carcinoma.
| 3 months after ESD initial procedure |
| Rate of histologically complete (R0) resection of low grade dysplasia | R0 resection rate = horizontal margins free from cancer, high or low grade dysplasia, and vertical margins free from carcinoma. | 3 months after ESD initial procedure |
| Curative resection rate of adenocarcinoma | R0 resection of adenocarcinoma, with submucosal invasion <500micrometers, absence of poor differenciation or lymphovascular invasion | 3 months after ESD initial procedure |
| Complication rates | early or late complications of ESD | 3 months |
| rate of complete remission of adenocarcinoma, high grade dysplasia, low grade dysplasia, and intestinal metaplasia at 1 and 3 years | rate of normal endoscopic and histologic follow-up after ESD | 3 years after initial procedure |
| rate of buried glands | Presence of Buried glands on histological analysis of follow-up biopsies | 3 years |
| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |