Informations générales (source: ClinicalTrials.gov)
French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy (MUCO-DUO)
Observational [Patient Registry]
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
janvier 2017
janvier 2022
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille - 13354 - Marseille - France | Philippe Grandval, MD/PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic
mucosectomy
- Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic
mucosectomy
- patients with previous endoscopic resection,
- patients prsenting lesion involving the major papilla, sub mucosal lesions
- patient with familial adenomatous polyposis
- patient undergoing use of antiplatelet agent during the five last days