Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE" (OESOFARE)

Status of Superficial Esophageal Cancers Treated by Endoscopy

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

Study Overview

• Status: Completed
• Conditions: Superficial Esophageal Cancers

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.

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigator will propose the study to any patient with esophageal cancer (adenocarcinoma or squamous cell carcinoma) or histologically proven high grade dysplasia and having an endoscopy for endoscopic resection of his oesophageal cancer or dysplasia. At least 100 patients will be included in the study

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of different managements according to the described method : The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon (Gastrointest. Endosc. 58, S3-43 (2003)	In this visit we noted the management by type and histological classification of superficial esophageal tumours	at the endoscopic resection procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy between the proposed management before the endoscopic procedure and the actual management	Percentage of adequacy between the proposed management before the endoscopic procedure and the actual management, defined by the respect of the envisaged strategy and timing	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of complete resection R0 after endoscopic treatment	Percentage of complete resection R0 after endoscopic treatment	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients with endoscopic complication per procedure and/or delayed	Percentage of patients with endoscopic complication per procedure (esophageal perforation, bleeding) and/or delayed (delayed bleeding, esophageal stenosis)	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients treated with mucosectomy or submucosal dissection	Percentage of patients treated with mucosectomy or submucosal dissection	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients having, in the month following the complementary treatment, an adverse effect	Number of patients having, in the month following the complementary treatment, an adverse effect such as fever, haemorrhage, retrosternal pain, food blockages or weight loss	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients with a recurrence of cancerous lesion at the initial resection site or at a distance, histologically proven	Number of patients with a recurrence of cancerous lesion at the initial resection site or at a distance, histologically proven, during follow-up consultations at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post treatment.	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients with recurrence having had a simple monitoring (= therapeutic abstention), endoscopic re-treatment, surgery or radiochemotherapy	Number of patients with recurrence having had a simple monitoring, endoscopic re-treatment, surgery or radiochemotherapy	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
"Esophageal Symptoms" questionnaire	Esophageal Symptoms questionnaires will be filled by the physician at each visit	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
"SF36" questionnaire	"SF36" questionnaires will be filled by the physician at each visit	at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): February 26, 2022
• Study Completion (Actual): February 26, 2025

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: therapeutic strategy; Superficial esophageal cancer; Endoscopic mucosectomy; Submucosal dissection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: RC18_0075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No