Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Neoplasms, Squamous Cell

Esophageal Cancer

Non interventional study

Emmanuel Coron, Pr

New tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma (SCC) in order to improve outcomes of this frequent and lethal cancer.

Optical coherence tomography (OCT) is an optical technique, which can image human tissue ex vivo and in vivo with a resolution around 30µm and with a depth of 1mm. Full-field optical coherence tomography (FFOCT) is a new modality, which allows to image an ex vivo specimen with a cellular resolution and to perform 3D reconstruction. This device has never been tested on esophageal specimens.

Therefore, the aim of this non-interventional research is 1) to determine FFOCT diagnostic criteria for SCC and 2) to figure if FFOCT allows the staging of the depth of invasion in SCC.

To achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of SCC (endoscopic mucosal resection (EMR) and submucosal dissection (ESD)) using an FFOCT device and we will compare the results with histological analysis of these specimens.

General study methodology

The study presents the following characteristics:

* Observational
* Non interventional imaging study
* Single-centre
* Not controlled
* Prospective Tests and analysis CRF
* Filled by the investigator
* Data from the medical file of the patient Imaging
* As standard of care
* Before endoscopic resection the lesion will be characterized and pictures will be made using white light endoscopy, magnification techniques and electronic chromoendoscopy
* Immediately after endoscopic resection, the specimen will be prepared, oriented and scanned using the FFOCT device (CE marking)
* Imaging movies will be then reviewed by trained readers and compared to movies of healthy patients, findings will be described
* Imaging movies will be compared to pathology slides

Pathology

* After scanning the specimen will be sent to pathology for analysis
* The pathology slides will be scanned to be kept in the study record together with their interpretation

Study schedule

* Total length of study: 24 months
* Methodology and regulatory: 6 months
* Recruitment period: 1 year
* Recruitment among the patients scheduled for the endoscopic procedure in the operative room
* One single visit = inclusion the day of the procedure
* No follow-up required
* Analyses: 3 months
* Paper writing: 3 months

Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study

The principal objective of this study will be reached if:

* the tumoral lesion is correctly identified in the specimen in FFOCT images
* and/or the normal esophageal mucosa and submucosal and/or normal vessels are correctly identified in the specimen in FFOCT images
* in at least 8 specimens.

Nantes University Hospital

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. 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.

Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"

Status of Superficial Esophageal Cancers Treated by Endoscopy

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

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

Percentage of complete resection R0 after endoscopic treatment

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

Percentage of patients treated with mucosectomy or submucosal dissection

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

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.

Number of patients with recurrence having had a simple monitoring, endoscopic re-treatment, surgery or radiochemotherapy

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study	NCT03467529	Esophagus Cance...	Non interventio...	18 Years -	Nantes University Hospital
Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"	NCT03674801	Superficial Eso...		18 Years -	Nantes University Hospital
Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study	NCT03467529	Esophagus Cance...	Non interventio...	18 Years -	Nantes University Hospital
Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"	NCT03674801	Superficial Eso...		18 Years -	Nantes University Hospital
Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"	NCT03674801	Superficial Eso...		18 Years -	Nantes University Hospital

Spots Global Cancer Trial Database for superficial esophageal cancer