French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

NCT03031704 | Unknown

• 1 other identifier: 2016-27
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of recurrence after surgery

  2 yeras

Study Arms (1)

Endoscopic mucosectomy

Procedure: Endoscopic mucosectomy

Interventions

Endoscopic mucosectomy PROCEDURE

Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.

Endoscopic mucosectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Philippe GRANDVAL, MD/PhD

CONTACT

philippe.grandval@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 26, 2017
• Study Start: January 9, 2017
• Primary Completion: January 9, 2021
• Study Completion: January 9, 2022
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)