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

Study Overview
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Brief Summary
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To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia

Detailed Description
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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?

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

Conditions
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Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis

Intervention / Treatment
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* Device: uncovered metal duodenal prosthesis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| symptomatic non-covered duodenal prosthesis<br>Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017. | Device: uncovered metal duodenal prosthesis<br>* Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia assessment | GOOSS = Gastric Outlet Obstruction Scoring System | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | Rate of complications | 7 years | 
| postoperative survival | defined as the time between the date of duodenal prosthesis insertion and the date of death or the latest news | 7 years | 
| Permeability duration of the duodenal stent | defined 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 | 7 years | 
| Rate of duodenal endoscopic resection at 1 and 3 months postoperatively | Rate of duodenal endoscopic resection at 1 and 3 months postoperatively | at 1 and 3 months postoperatively | 
| Rate of biliary endoscopic resection at 1 and 3 months postoperatively | Rate of biliary endoscopic resection at 1 and 3 months postoperatively | at 1 and 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duodenal stenosis, pyloric stenosis, digestive neoplasias, non-digestive neoplasias, duodenal prosthesis