French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

NCT ID: NCT03031704

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2022-01-09

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.

Conditions

Duodenal Adenoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic mucosectomy

Endoscopic mucosectomy

Intervention Type: PROCEDURE

Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.

Interventions

Endoscopic mucosectomy

Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe GRANDVAL, MD/PhD

Role: CONTACT

philippe.grandval@ap-hm.fr

Facility Contacts

Philippe Grandval, MD/PhD

Role: primary

philippe.grandval@ap-hm.fr

Other Identifiers

2016-27

Identifier Type: -

Identifier Source: org_study_id