Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"

NCT ID: NCT03674801

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 151 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-26
• Study Completion Date: 2025-02-26

Brief Summary

In 2013, esophageal cancer was the 9th cause of cancer in the world and the 6th in terms of cancer mortality. The prognosis of this cancer varies according to geographical areas, but in Europe and the USA, the 5-year survival rate has risen from less than 5% in the 1960s to around 20% in the 2000s. In the United States, however, the survival rate has risen from 5% in the 1960s to around 20% in the 2000s.

Increased the detection of premalignant lesions and early stages may improve prognosis. The presence of esophageal cancer is determined by endoscopy, biopsy and histological confirmation. However, endoscopic techniques (mucosectomy and sub mucosal dissection) are also used as curative treatment for early esophageal lesions.

Now, due to the low number of diagnoses of esophageal tumours at the superficial stage, few studies are available in Europe on the efficacy of these endoscopic techniques and on the complications resulting from their use. Similarly, little is known about the complications of endoscopic techniques and about therapeutic strategies for managing these superficial lesions. In particular, no data are available concerning the adequacy between the treatment proposed in multidisciplinary consultation meetings and the actual management of patients.

Our study is therefore fundamental to make an inventory of superficial esophageal cancers treated by endoscopy, and their management

Detailed Description

This fundamental study will therefore best describe current French practices for the management strategy of esophageal cancers after endoscopic treatment. Consequently, the interests of this study, national inventory, are multiple:

1. List a significant number of endoscopic treatments. In particular, by sub mucosal dissection in France, in order to strengthen scientific evidence of its efficacy, to assess its feasibility and complication rate.

2. Describe the therapeutic strategies currently in place during endoscopic treatment,

3. Evaluate the adequacy between the proposed upstream management of the endoscopic procedure by SCP and the actual management.

Conditions

Superficial Esophageal Cancers

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Male or female over 18 years of age
• Patient with histologically proven high-grade esophageal cancer (adenocarcinoma or squamous cell carcinoma) or dysplasia
• Patient with digestive endoscopy for endoscopic resection (mucosectomy or submucosal dissection) of a cancerous lesion (adenocarcinoma or squamous cell carcinoma) of the esophagus or high-grade dysplasia.
• Patient who received the study briefing note and agreed to participate

Exclusion Criteria

• Failure to perform the endoscopic procedure
• Patient under guardianship or guardianship or under judicial safeguard measure
• Pregnant woman
• Patient with prior treatment for esophageal cancer.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Nantes

Nantes, , France

Countries

France

Other Identifiers

RC18_0075

Identifier Type: -

Identifier Source: org_study_id