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NCT Number: NCT07343869

Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection

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.

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Key information

Conditions

Superficial Esophageal Cancer Adenocarcinoma Of Esophagus Barretts Esophagus With Dysplasia Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oesophageal Adenocarcinoma Oesophageal Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jules Verne Clinic

Nantes, 44300, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. R0 resection rate

    Time frame: From ESD to 5 years

    Proportion of patients with tumor-free lateral and deep margins confirmed by histopathology.

  2. En bloc resection rate

    Time frame: From ESD to 5 years

    Proportion of lesions resected in a single piece exclusively by ESD.

  3. 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).

  4. 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.

  5. Rate of MDTB presentation

    Time frame: From ESD to 5 years

    Proportion of patients whose management was discussed in a multidisciplinary team meeting.

  6. 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.

  7. 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.).

  8. 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.

  9. Morbidity of complementary treatments

    Time frame: From ESD to 5 years

    Rate of complications related to adjuvant therapy or Barrett's treatment

  10. 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

  11. 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.

  12. 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.

  13. Predictive factors for R0 resection

    Time frame: From ESD to 5 years

    Analysis of clinical, endoscopic, and procedural variables predictive of complete R0 resection.

  14. 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.

  15. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand BB BRIEAU, MD

CONTACT

[email protected]

+33650266383 ext. +33

Maira MORENO, PhD

CONTACT

[email protected]

+33(0)472117513

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Acronym: FEO

Important dates

Study start
2026
Primary completion
2031
Study completion
2036
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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