Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.

Endoscopic mucosectomy

Philippe GRANDVAL, MD/PhD

Philippe Grandval, MD/PhD

Urielle DESALBRES

Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than that can be observed for colorectal adenomas. As no prospective data have been published this French multicenter study aim to analyze results of this technique under standardized and secured procedure.

All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly expected among the international society of gastroenterologists who need to confirm the efficacy of endoscopy and define optimal conditions for performing adenomas resection in this location Primary End Point is the two years recurrence rate. Secondary End Points are frequency and type of complication after standardized endoscopic mucosectomy of duodenal adenomas, frequency and type of complications after a second endoscopic mucosectomy and patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions, familial adenomatous polyposis and use of antiplatelet agent during the five last days.

Hundred and twenty patients will be included and followed 2 years after mucosectomy.

French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

Assistance Publique Hopitaux De Marseille

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

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
French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy	NCT03031704	Duodenal Adenom...	Endoscopic muco...	18 Years -	Assistance Publique Hopitaux De Marseille
French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy	NCT03031704	Duodenal Adenom...	Endoscopic muco...	18 Years -	Assistance Publique Hopitaux De Marseille
French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy	NCT03031704	Duodenal Adenom...	Endoscopic muco...	18 Years -	Assistance Publique Hopitaux De Marseille
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
Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"	NCT03674801	Superficial Eso...		18 Years -	Nantes University Hospital

Spots Global Cancer Trial Database for endoscopic mucosectomy