Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection

NCT07343869 | Not Yet Recruiting

• 1 other identifier: SFED-162
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

In France in 2018, there were an estimated 2,074 new cases of esophageal adenocarcinoma and 3,224 cases of squamous cell carcinoma. The estimated deaths from esophageal cancer were 3,725, with a standardized 5-year net survival rate of 20% for cases diagnosed between 2010 and 2015, mainly due to late diagnosis. Surgery was historically the standard treatment for localized disease but carries significant morbidity. Over the past decade, endoscopic treatments, particularly endoscopic submucosal dissection (ESD), have become the reference approach for superficial esophageal cancers. After endoscopic resection, histological analysis allows classification of recurrence risk into very low, low, and high categories. Predicting lymph node or distant recurrence is complex, depending on factors such as depth of wall infiltration, lymphovascular invasion, and tumor differentiation. The frequent combination of unfavorable histological features may have led to an overestimation of lymph node involvement risk in T1b cancers. ESD is widely performed in France, with over 1,600 procedures reported in 2023 for esophageal and gastric lesions, demonstrating the feasibility of a large observational study. This multicenter French cohort will evaluate technical, oncological, and organizational outcomes of esophageal ESD, including overall survival, recurrence-free survival, and management of residual Barrett's esophagus. It will also identify predictive factors for treatment success, recurrence, and complications, providing real-world evidence to guide patient management.

Conditions

Oesophageal Squamous Cell Carcinoma; Barretts Esophagus With Dysplasia; Superficial Esophageal Cancer; Oesophageal Adenocarcinoma

Keywords

Endoscopic esophageal disection; Endoscopic resection; Endoscopic submucosal dissection; Curative resection

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival according to adjuvant treatment

  Recurrence-free survival will be evaluated in patients after endoscopic submucosal dissection (ESD) of superficial esophageal carcinoma. Patients may receive adjuvant therapy (surgery, chemotherapy, or chemoradiotherapy) at the treating physician's discretion. Recurrence includes local, regional, or metastatic relapse as defined by clinical, endoscopic, and imaging criteria and validated by multidisciplinary team discussion. Recurrence will be monitored throughout the 5-year follow-up period to compare outcomes between patients receiving adjuvant therapy versus surveillance.

  From enrollment to 5 years

Secondary Outcomes (15)

• R0 resection rate

  From ESD to 5 years

• En bloc resection rate

  From ESD to 5 years

• Curative resection rate

  From ESD to 5 years

• 30-day complication rate

  30 days post-ESD

• Rate of MDTB presentation

  From ESD to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients include all individuals referred to a participating center for endoscopic resection of an esophageal lesion and treated by submucosal dissection. This is a prospective, multicenter, observational study, conducted on an intention-to-treat basis. All consecutive patients referred for esophageal ESD will be included.

You may qualify if:

• Adults (≥ 18 years old)
• Patients referred for endoscopic resection of an esophageal lesion and treated by submucosal dissection
• Patients managed in one of the participating centers
• Patient who has received oral and written information about the study and has not objected to participation
• Patients covered by a social security or health insurance scheme.

You may not qualify if:

• Patient refusal after reading the information sheet
• Patient under legal protection (guardianship, curatorship, court-ordered protection)
• Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency
• Patients previously included for another lesion in the same study
• Pregnant or breastfeeding women.
• Patient deprived of liberty.
• Patient currently enrolled in another clinical trial.

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Jules Verne Clinic

Nantes, 44300, France

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Bertrand BB BRIEAU, MD

CONTACT

+33650266383; bertrand.brieau@gmail.com

Maira MORENO, PhD

CONTACT

+33(0)472117513; rechercheclinique@sfed.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical doctor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): February 1, 2036
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)