French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy (MUCO-DUO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03031704|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
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.
|Condition or disease||Intervention/treatment|
|Duodenal Adenoma||Procedure: Endoscopic mucosectomy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||24 Months|
|Official Title:||French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy|
|Actual Study Start Date :||January 9, 2017|
|Estimated Primary Completion Date :||January 9, 2021|
|Estimated Study Completion Date :||January 9, 2022|
Procedure: Endoscopic mucosectomy
Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.
- Number of recurrence after surgery [ Time Frame: 2 yeras ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031704
|Contact: Philippe GRANDVAL, MD/PhDemail@example.com|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Philippe Grandval, MD/PhD firstname.lastname@example.org|
|Study Director:||Urielle DESALBRES||Assistance Publique Hôpitaux de Marseille|