Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociété Française d'Endoscopie Digestive

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
From enrollment to 5 years

Secondary outcomes

1

R0 resection rate

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

Time frame
From ESD to 5 years
2

En bloc resection rate

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

Time frame
From ESD to 5 years
3

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).

Time frame
From ESD to 5 years
4

30-day complication rate

Rate of per- or post-procedural bleeding, immediate or delayed perforation, and strictures requiring endoscopic dilation.

Time frame
30 days post-ESD

Other outcomes

Sponsors and contacts

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