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Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years

Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03463668
Acronym
DYSPHAGIE
Enrollment
200
Registered
2018-03-13
Start date
2017-12-22
Completion date
2029-12-31
Last updated
2018-03-13

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

Conditions

Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis

Keywords

duodenal stenosis, pyloric stenosis, digestive neoplasias, non-digestive neoplasias, duodenal prosthesis

Brief summary

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

Detailed 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?

Interventions

DEVICEuncovered metal duodenal prosthesis

Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

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)

Design outcomes

Primary

MeasureTime frameDescription
Dysphagia assessment7 yearsGOOSS = Gastric Outlet Obstruction Scoring System

Secondary

MeasureTime frameDescription
Rate of complications7 yearsRate of complications
postoperative survival7 yearsdefined as the time between the date of duodenal prosthesis insertion and the date of death or the latest news
Permeability duration of the duodenal stent7 yearsdefined as the time between the date of the laying of the duodenal stent and date of patient's death or RED or surgery (exceptional case) or latest news
Rate of duodenal endoscopic resection at 1 and 3 months postoperativelyat 1 and 3 months postoperativelyRate of duodenal endoscopic resection at 1 and 3 months postoperatively
Rate of biliary endoscopic resection at 1 and 3 months postoperativelyat 1 and 3 months postoperativelyRate of biliary endoscopic resection at 1 and 3 months postoperatively

Countries

France

Contacts

Primary ContactFabrice CAILLOL
CAILLOLF@ipc.unicancer.fr0491223531
Backup ContactJean-Philippe RATONE
RATONEJ@ipc.unicancer.fr0491227727

Outcome results

None listed

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