ESD for the Treatment of Early Barrett's Neoplasia (ESTEBAN)

Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia

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.

Study Overview

• Status: Unknown
• Conditions: Barrett Esophagus; Esophageal Neoplasm
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Cochin Hospital
    • Contact: Maximilien Barret, MD, PhD; Phone Number: 0033158414285; Email: maximilien.barret@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hôpital Cochin
• Collaborators: University Hospital, Bordeaux; Centre Hospitalier Universitaire de Nice; University Hospital, Limoges; Hôpital Edouard Herriot; European Georges Pompidou Hospital; French Society of Digestive Endoscopy; Hospital Prive Jean Mermoz

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2016
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; Esophageal adenocarcinoma; Barrett esophagus
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Precancerous Conditions; Esophageal Neoplasms; Barrett Esophagus
• Other Study ID Numbers: 20102015