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

NCT ID: NCT02859883

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-18

Study Completion Date

2016-05-31

Brief Summary

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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 Description

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Conditions

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Adenoma of the Accessory Papilla Ampulloma of the Accessory Papilla

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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gastroscope FUSE™

All patients undergoing a diagnostic gastroscopy are eligible. Using the FUSE endoscope with side screen, the duodenal and accessory papilla are monitored. Data are collected by each operator. Clinical examination of patients is performed before they leave the centre.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient eligible to any upper gastrointestinal endoscopy diagnostic

Exclusion Criteria

* History of duodenal or gastric surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe RATONE, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli Calmettes

Marseille, Bouches du Rhone, France

Site Status

Countries

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France

References

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Gralnek IM, Segol O, Suissa A, Siersema PD, Carr-Locke DL, Halpern Z, Santo E, Domanov S. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013 Sep;45(9):697-702. doi: 10.1055/s-0033-1344395. Epub 2013 Aug 12.

Reference Type BACKGROUND
PMID: 23939509 (View on PubMed)

Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20.

Reference Type BACKGROUND
PMID: 24560453 (View on PubMed)

Moussata D, Napoleon B, Lepilliez V, Klich A, Ecochard R, Lapalus MG, Nancey S, Cenni JC, Ponchon T, Chayvialle JA, Saurin JC. Endoscopic treatment of severe duodenal polyposis as an alternative to surgery for patients with familial adenomatous polyposis. Gastrointest Endosc. 2014 Nov;80(5):817-25. doi: 10.1016/j.gie.2014.03.012. Epub 2014 May 6.

Reference Type BACKGROUND
PMID: 24814771 (View on PubMed)

Other Identifiers

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FUSE-TM-Duodénum-IPC 2015-001

Identifier Type: -

Identifier Source: org_study_id