Superficial Esophageal Cancers Clinical Trial
— OESOFAREOfficial title:
Status of Superficial Esophageal Cancers Treated by Endoscopy
| Verified date | September 2023 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | February 26, 2027 |
| Est. primary completion date | February 26, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Nantes | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | "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 | |
| Secondary | "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 |