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Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years (DYSPHAGIE)

I

Institut Paoli-Calmettes

Status

Enrolling

Conditions

Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis

Treatments

Device: uncovered metal duodenal prosthesis

Study type

Observational

Funder types

Other

Identifiers

NCT03463668
DYSPHAGIE-IPC 2017-036

Details and patient eligibility

About

To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia

Full description

Duodenal prostheses have become, since the 2000s, the first-line treatment of unresectable duodenal tumoral stenosis. The technical success is greater than 90%, however the endoscopic revisions that are duodenal or biliary are frequent. The IPC as a center of interventional endoscopy is very often in charge of these stenoses. We wanted to evaluate the efficiency and the duration of this effectiveness in current situation. Is there still room for gastrojejunal gastrojejunal surgery or for the development of endoscopic gastrojejunal anastomoses?

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.

Exclusion criteria

  • Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)

Trial design

200 participants in 1 patient group

symptomatic non-covered duodenal prosthesis
Description:
Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.
Treatment:
Device: uncovered metal duodenal prosthesis

Trial contacts and locations

1

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Central trial contact

Fabrice CAILLOL; Jean-Philippe RATONE

Data sourced from clinicaltrials.gov

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