ESTEBAN: ESD for the Treatment of Early Barrett's Neoplasia

• Sponsor: Hôpital Cochin (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02583087
• Collaborator: French Society of Digestive Endoscopy (Other), European Georges Pompidou Hospital (Other), Hôpital Edouard Herriot (Other), Hospital Prive Jean Mermoz (Other), University Hospital, Limoges (Other), University Hospital, Bordeaux (Other), Centre Hospitalier Universitaire de Nice (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 74.9
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus; Esophageal Neoplasm	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia
• Actual Study Start Date: Jan 2, 2016
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Apr 1, 2022

Outcome Measures

Primary Outcome Measures

1. Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia [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 Outcome Measures

1. Rate of en bloc resection via ESD [3 months after ESD initial procedure]

   presence of a single fragment of tissue on histopathological analysis

2. Rate of histologically complete (R0) resection of esophageal adenocarcinoma [3 months after ESD initial procedure]

   R0 resection rate = horizontal margins free from cancer, and vertical margins free from carcinoma.

3. Rate of histologically complete (R0) resection of low grade dysplasia [3 months after ESD initial procedure]

   R0 resection rate = horizontal margins free from cancer, high or low grade dysplasia, and vertical margins free from carcinoma.

4. Curative resection rate of adenocarcinoma [3 months after ESD initial procedure]

   R0 resection of adenocarcinoma, with submucosal invasion <500micrometers, absence of poor differenciation or lymphovascular invasion

5. Complication rates [3 months]

   early or late complications of ESD

6. 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]

   rate of normal endoscopic and histologic follow-up after ESD

7. rate of buried glands [3 years]

   Presence of Buried glands on histological analysis of follow-up biopsies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cochin Hospital	Paris		France	75014

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frederic PRAT, Professor Frederic Prat, Hôpital Cochin
• ClinicalTrials.gov Identifier: NCT02583087
• Other Study ID Numbers: 20102015
• First Posted: Oct 21, 2015
• Last Update Posted: Aug 28, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Frederic PRAT, Professor Frederic Prat, Hôpital Cochin: Barrett esophagus; Esophageal adenocarcinoma; Endoscopic submucosal dissection
• Additional relevant MeSH terms: Barrett Esophagus; Esophageal Neoplasms

Study Results

No Results Posted as of Aug 28, 2017