Clinical trial NCT03674801: Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"
Official title: Status of Superficial Esophageal Cancers Treated by Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Esophageal Cancers
Keywords: Superficial esophageal cancer
Endoscopic mucosectomy
Submucosal dissection
therapeutic strategy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: 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)
timeFrame: at the endoscopic resection procedure
Secondary outcomes:
measure: Adequacy between the proposed management before the endoscopic procedure and the actual management
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Percentage of complete resection R0 after endoscopic treatment
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Percentage of patients with endoscopic complication per procedure and/or delayed
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Percentage of patients treated with mucosectomy or submucosal dissection
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Number of patients having, in the month following the complementary treatment, an adverse effect
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Number of patients with a recurrence of cancerous lesion at the initial resection site or at a distance, histologically proven
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Number of patients with recurrence having had a simple monitoring (= therapeutic abstention), endoscopic re-treatment, surgery or radiochemotherapy
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: "Esophageal Symptoms" questionnaire
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: "SF36" questionnaire
timeFrame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References: