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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Endoscopic mucosectomy Procedure: Endoscopic mucosectomy
Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.




Primary Outcome Measures :
  1. Number of recurrence after surgery [ Time Frame: 2 yeras ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included
Criteria

Inclusion Criteria:

  • Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Philippe GRANDVAL, MD/PhD philippe.grandval@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Philippe Grandval, MD/PhD       philippe.grandval@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
Additional Information:

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03031704    
Other Study ID Numbers: 2016-27
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms