Skip to main content
OpenTrials
Completed

NCT Number: NCT03674801

Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Superficial Esophageal Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes

Nantes, 44000, France

About this study

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:

  • 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.
  • Describe the therapeutic strategies currently in place during endoscopic treatment,
  • Evaluate the adequacy between the proposed upstream management of the endoscopic procedure by SCP and the actual management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

    Time frame: at the endoscopic resection procedure

    In this visit we noted the management by type and histological classification of superficial esophageal tumours

Secondary outcomes

  1. Adequacy between the proposed management before the endoscopic procedure and the actual management

    Time frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

    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

  2. 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 complete resection R0 after endoscopic treatment

  3. Percentage of patients with endoscopic complication per procedure and/or delayed

    Time frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

    Percentage of patients with endoscopic complication per procedure (esophageal perforation, bleeding) and/or delayed (delayed bleeding, esophageal stenosis)

  4. Percentage of patients treated with mucosectomy or submucosal dissection

    Time frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

    Percentage of patients treated with mucosectomy or submucosal dissection

  5. Number of patients having, in the month following the complementary treatment, an adverse effect

    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 such as fever, haemorrhage, retrosternal pain, food blockages or weight loss

  6. Number of patients with a recurrence of cancerous lesion at the initial resection site or at a distance, histologically proven

    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, during follow-up consultations at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post treatment.

  7. Number of patients with recurrence having had a simple monitoring (= therapeutic abstention), endoscopic re-treatment, surgery or radiochemotherapy

    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, endoscopic re-treatment, surgery or radiochemotherapy

  8. "Esophageal Symptoms" questionnaire

    Time frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

    Esophageal Symptoms questionnaires will be filled by the physician at each visit

  9. "SF36" questionnaire

    Time frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

    "SF36" questionnaires will be filled by the physician at each visit

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Status of Superficial Esophageal Cancers Treated by Endoscopy

Acronym: OESOFARE

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Sep 18, 2018
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.