Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia
Time Frame: 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 Outcomes
- 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 buried glands(3 years)
- Rate of histologically complete (R0) resection of low grade dysplasia(3 months after ESD initial procedure)
- Complication rates(3 months)
- Curative resection rate of adenocarcinoma(3 months after ESD initial procedure)
- 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)
Investigators
Frederic PRAT
Professor Frederic Prat
Hôpital Cochin