ESD for the Treatment of Early Barrett's Neoplasia

Barrett Esophagus Clinical Trial

— ESTEBAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583087
• Other study ID #: 20102015
• Status: Recruiting
• Phase: N/A
• First received: October 20, 2015
• Last updated: August 25, 2017
• Start date: January 2, 2016
• Est. completion date: April 2022

Study information

• Verified date: August 2017
• Source: Hôpital Cochin
• Contact: Frederic Prat, MD, PhD
• Phone: 00331 58 41 19 85
• Email: frederic.prat[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2022
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

Procedure:
• endoscopic submucosal dissection
Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (8)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of en bloc resection via ESD	presence of a single fragment of tissue on histopathological analysis	3 months after ESD initial procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Complication rates	early or late complications of ESD	3 months
Secondary	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
Secondary	rate of buried glands	Presence of Buried glands on histological analysis of follow-up biopsies	3 years