Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: uncovered metal duodenal prosthesis.
- Who it may be relevant to
- Registry conditions: Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device uncovered metal duodenal prosthesis
Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis
Primary outcome measures
- Dysphagia assessment [Time frame: 7 years]
Secondary outcome measures (5)
- Rate of complications [Time frame: 7 years]
- postoperative survival [Time frame: 7 years]
- Permeability duration of the duodenal stent [Time frame: 7 years]
- Rate of duodenal endoscopic resection at 1 and 3 months postoperatively [Time frame: at 1 and 3 months postoperatively]
- Rate of biliary endoscopic resection at 1 and 3 months postoperatively [Time frame: at 1 and 3 months postoperatively]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Institut Paoli Calmettes — Marseille
Publications
- Fiori E, Lamazza A, Volpino P, Burza A, Paparelli C, Cavallaro G, Schillaci A, Cangemi V. Palliative management of malignant antro-pyloric strictures. Gastroenterostomy vs. endoscopic stenting. A randomized prospective trial. Anticancer Res. 2004 Jan-Feb;24(1):269-71. PMID 15015607
- Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3. PMID 15457364
- Jeurnink SM, Steyerberg EW, Hof Gv, van Eijck CH, Kuipers EJ, Siersema PD. Gastrojejunostomy versus stent placement in patients with malignant gastric outlet obstruction: a comparison in 95 patients. J Surg Oncol. 2007 Oct 1;96(5):389-96. doi: 10.1002/jso.20828. PMID 17474082
- ASGE guidelines enteral stents
Identifiers
NCT: NCT03463668 · DYSPHAGIE-IPC 2017-036