Clinical trial NCT02583087: ESD for the Treatment of Early Barrett's Neoplasia
Official title: Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Barrett Esophagus
Esophageal Neoplasm
Keywords: Barrett esophagus
Esophageal adenocarcinoma
Endoscopic submucosal dissection
Lead sponsor: Hôpital Cochin
Sponsor class: OTHER
Collaborators: name: French Society of Digestive Endoscopy
name: European Georges Pompidou Hospital
name: Hôpital Edouard Herriot
name: Hospital Prive Jean Mermoz
name: University Hospital, Limoges
name: University Hospital, Bordeaux
name: Centre Hospitalier Universitaire de Nice
First posted: 2015-10-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia
timeFrame: 3 months after ESD initial procedure
Secondary outcomes:
measure: Rate of en bloc resection via ESD
timeFrame: 3 months after ESD initial procedure
measure: Rate of histologically complete (R0) resection of esophageal adenocarcinoma
timeFrame: 3 months after ESD initial procedure
measure: Rate of histologically complete (R0) resection of low grade dysplasia
timeFrame: 3 months after ESD initial procedure
measure: Curative resection rate of adenocarcinoma
timeFrame: 3 months after ESD initial procedure
measure: Complication rates
timeFrame: 3 months
measure: rate of complete remission of adenocarcinoma, high grade dysplasia, low grade dysplasia, and intestinal metaplasia at 1 and 3 years
timeFrame: 3 years after initial procedure
measure: rate of buried glands
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
References: