Superficial Esophageal CancerFEONCT07343869
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
An observational study of Superficial Esophageal Cancer and Oesophageal Adenocarcinoma, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Esophageal Cancer, Oesophageal Adenocarcinoma, Oesophageal Squamous Cell Carcinoma
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 1 Feb 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Superficial Esophageal Cancer, Oesophageal Adenocarcinoma, Oesophageal Squamous Cell Carcinoma, Barretts Esophagus With Dysplasia
- Keywords
- Endoscopic esophageal disection, Endoscopic resection, Endoscopic submucosal dissection, Curative resection
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 5 years
Secondary outcomes (15)
R0 resection rate
Proportion of patients with tumor-free lateral and deep margins confirmed by histopathology.
Measured: From ESD to 5 years
En bloc resection rate
Proportion of lesions resected in a single piece exclusively by ESD.
Measured: From ESD to 5 years
Curative resection rate
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).
Measured: From ESD to 5 years
30-day complication rate
Rate of per- or post-procedural bleeding, immediate or delayed perforation, and strictures requiring endoscopic dilation.
Measured: 30 days post-ESD
Rate of MDTB presentation
Proportion of patients whose management was discussed in a multidisciplinary team meeting.
Measured: From ESD to 5 years
Concordance between MDTB decision and actual management
Proportion of patients for whom the implemented management matched the MDTB recommendation.
Measured: From ESD to 5 years
Rate of patients receiving adjuvant treatment
Proportion of patients receiving any adjuvant therapy after ESD (surgery, radiotherapy, chemotherapy, immunotherapy, etc.).
Measured: From enrollment to 5 years
Rate of complementary Barrett's eradication treatment (radiofrequency or other)
Proportion of patients treated for residual Barrett's esophagus using radiofrequency ablation or other endoscopic techniques.
Measured: From ESD to 5 years
Morbidity of complementary treatments
Rate of complications related to adjuvant therapy or Barrett's treatment
Measured: From ESD to 5 years
Efficacy of complementary treatments
Rate of complete remission of intestinal metaplasia or oncologic control following complementary tratmets
Measured: From complementary treatment to 5 years
Prognostic factors for recurrence (local, regional, metastatic)
Identification of clinical, endoscopic, and histological variables associated with increased risk of recurrence, analyzed using univariate and multivariate methods.
Measured: From enrollment to 5 years
Predictive factors for post-ESD complications
Analysis of factors associated with immediate or delayed complications (bleeding, perforation, stenosis) according to patient characteristics, ESD procedure, and adjuvant therapy.
Measured: From ESD to 5 years
Predictive factors for R0 resection
Analysis of clinical, endoscopic, and procedural variables predictive of complete R0 resection.
Measured: From ESD to 5 years
Diagnostic accuracy of optical endoscopic classifications vs. histology
Accuracy of endoscopic optical classifications in predicting histology prior to resection, compared to histopathology results.
Measured: From ESD to pathology report
Impact of center volume on outcomes
Evaluation of the influence of annual ESD procedure volume in a center on technical and oncologic outcomes
Measured: From enrollment to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertrand Brieau, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343869
- Sponsor's protocol ID
- SFED-162
- Acronym
- FEO
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided