Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection (FEO)

January 7, 2026 updated by: Bertrand Brieau, Société Française d'Endoscopie Digestive

Prospective Multicenter Cohort on Esophageal Submucosal Dissection: Evaluation of Technical, Oncological, and Organizational Outcomes in Real-Life Practice

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nantes, France, 44300
        • Jules Verne Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival according to adjuvant treatment
Time Frame: From enrollment to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: From ESD to 5 years
Proportion of patients with tumor-free lateral and deep margins confirmed by histopathology.
From ESD to 5 years
En bloc resection rate
Time Frame: From ESD to 5 years
Proportion of lesions resected in a single piece exclusively by ESD.
From ESD to 5 years
Curative resection rate
Time Frame: From ESD to 5 years
Proportion of R0 resections meeting favorable histological criteria: no lymphovascular invasion, no tumor budding, well-differentiated tumor, submucosal invasion <200 µm (squamous cell carcinoma) or <500 µm (adenocarcinoma).
From ESD to 5 years
30-day complication rate
Time Frame: 30 days post-ESD
Rate of per- or post-procedural bleeding, immediate or delayed perforation, and strictures requiring endoscopic dilation.
30 days post-ESD
Rate of MDTB presentation
Time Frame: From ESD to 5 years
Proportion of patients whose management was discussed in a multidisciplinary team meeting.
From ESD to 5 years
Concordance between MDTB decision and actual management
Time Frame: From ESD to 5 years
Proportion of patients for whom the implemented management matched the MDTB recommendation.
From ESD to 5 years
Rate of patients receiving adjuvant treatment
Time Frame: From enrollment to 5 years
Proportion of patients receiving any adjuvant therapy after ESD (surgery, radiotherapy, chemotherapy, immunotherapy, etc.).
From enrollment to 5 years
Rate of complementary Barrett's eradication treatment (radiofrequency or other)
Time Frame: From ESD to 5 years
Proportion of patients treated for residual Barrett's esophagus using radiofrequency ablation or other endoscopic techniques.
From ESD to 5 years
Morbidity of complementary treatments
Time Frame: From ESD to 5 years
Rate of complications related to adjuvant therapy or Barrett's treatment
From ESD to 5 years
Efficacy of complementary treatments
Time Frame: From complementary treatment to 5 years
Rate of complete remission of intestinal metaplasia or oncologic control following complementary tratmets
From complementary treatment to 5 years
Prognostic factors for recurrence (local, regional, metastatic)
Time Frame: From enrollment to 5 years
Identification of clinical, endoscopic, and histological variables associated with increased risk of recurrence, analyzed using univariate and multivariate methods.
From enrollment to 5 years
Predictive factors for post-ESD complications
Time Frame: From ESD to 5 years
Analysis of factors associated with immediate or delayed complications (bleeding, perforation, stenosis) according to patient characteristics, ESD procedure, and adjuvant therapy.
From ESD to 5 years
Predictive factors for R0 resection
Time Frame: From ESD to 5 years
Analysis of clinical, endoscopic, and procedural variables predictive of complete R0 resection.
From ESD to 5 years
Diagnostic accuracy of optical endoscopic classifications vs. histology
Time Frame: From ESD to pathology report
Accuracy of endoscopic optical classifications in predicting histology prior to resection, compared to histopathology results.
From ESD to pathology report
Impact of center volume on outcomes
Time Frame: From enrollment to 5 years
Evaluation of the influence of annual ESD procedure volume in a center on technical and oncologic outcomes
From enrollment to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société Française d'Endoscopie Digestive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

February 1, 2036

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFED-162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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