Clinical Trial: Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

Brief Summary: The monitoring and prognosis of patients with familial polyposis adenomatous rests on analysis of the transitional mucosa at the anal margin and especially on the tracking, characterization and resection of lesions of dysplasia type of high grade at the duodenal level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are used. The FUSE technology allows the simplification or even the improvement of patient surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a second screen to enlarge the field of view may allow both analysis of duodenum and the main and accessory papilla with one single endoscope and to decrease the number of omitted lesions .

Detailed Summary:
Sponsor: Institut Paoli-Calmettes

Current Primary Outcome: Efficacy [ Time Frame: 1 day ]

Visualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of patient with treatment-related serious adverse events [ Time Frame: 5 day ]

Evaluated serious advers events are mainly perforation, severe bleeding, acute pancreatitis


Original Secondary Outcome: Same as current

Information By: Institut Paoli-Calmettes

Dates:
Date Received: August 2, 2016
Date Started: March 2015
Date Completion: December 2017
Last Updated: March 1, 2017
Last Verified: January 2017