Duodenal Adenoma Clinical Trial
Official title:
French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy
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.
n/a
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