An observational study in Superficial Esophageal Cancers, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Nantes University Hospital · Observational
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
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:
1,593 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.
This study's enrollment of 151 is below the median of 200 across 340 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
Time frame: at the endoscopic resection procedure
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital