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

Recruiting

• Conditions: Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis
• Interventions: Device: uncovered metal duodenal prosthesis

• Registration Number: NCT03463668
• Lead Sponsor: Institut Paoli-Calmettes

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?

Study Timeline

• Study Start: 2017-12-22
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-12
• Last Update Submitted: 2018-03-12
• Study First Posted: 2018-03-13
• Last Update Posted: 2018-03-13
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
symptomatic non-covered duodenal prosthesis	uncovered metal duodenal prosthesis	Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.

Primary Outcome Measures

Name	Time	Method
Dysphagia assessment	7 years	GOOSS = Gastric Outlet Obstruction Scoring System

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France