An observational study in Barrett Esophagus and Esophageal Neoplasm, sponsored by Hôpital Cochin. Status unknown at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-08-28.
Sponsored by Hôpital Cochin · Observational
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.
312 studies on the registry are indexed under Barrett Esophagus; 60 are open to participants now.
This study's planned enrollment of 150 is close to the median of 144 across 118 observational studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Hôpital Cochin is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 3 months after ESD initial procedure
Rate of en bloc resection via ESD
presence of a single fragment of tissue on histopathological analysis
Time frame: 3 months after ESD initial procedure
Rate of histologically complete (R0) resection of esophageal adenocarcinoma
R0 resection rate = horizontal margins free from cancer, and vertical margins free from carcinoma.
Time frame: 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.
Time frame: 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
Time frame: 3 months after ESD initial procedure
Complication rates
early or late complications of ESD
Time frame: 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
Time frame: 3 years after initial procedure
rate of buried glands
Presence of Buried glands on histological analysis of follow-up biopsies
Time frame: 3 years
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Hôpital Cochin