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French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03031704
Acronym
MUCO-DUO
Enrollment
120
Registered
2017-01-26
Start date
2017-01-09
Completion date
2022-01-09
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Adenoma

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.

Interventions

Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of recurrence after surgery2 yeras

Countries

France

Contacts

Primary ContactPhilippe GRANDVAL, MD/PhD
philippe.grandval@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026