Evaluating the effectiveness of uncovered duodenal prostheses for treating duodenal stenosis
Official title: Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
Run by Institut Paoli-Calmettes · NCT03463668 · Data updated 2026-11-12
This study is testing if uncovered metal tubes can help people with blocked intestines due to tumors feel better and how long they work before more treatment is needed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille, Bouches Du Rhone) |
| Status | Recruiting |
| Started | December 22, 2017 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | March 13, 2018 |
| Trial ID | NCT03463668 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with symptomatic duodenal stenosis due to unresectable tumors who received uncovered duodenal prostheses between 2010 and 2017.
✕Probably not a fit
Patients with benign stenosis or those who have received covered metallic duodenal prostheses will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the efficacy of uncovered metal duodenal prostheses in patients with symptomatic duodenal stenosis caused by digestive or non-digestive neoplasia. The study will evaluate the technical success rate and the duration of effectiveness of these prostheses, which have been the first-line treatment since the 2000s. It will also explore the potential need for surgical interventions or endoscopic procedures in cases where prostheses are used. Data will be collected from patients who received these prostheses between 2010 and 2017.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term effectiveness of duodenal prostheses, improving treatment strategies for patients with duodenal stenosis.
How similar studies have gone: While the use of duodenal prostheses has been established, this study aims to provide new insights into their long-term efficacy, making it a valuable addition to existing knowledge rather than a completely novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France Recruiting
Study contacts
- Principal investigator: Fabrice CAILLOL — Institut Paoli-Calmettes
- Study coordinator: Fabrice CAILLOL
- Email: CAILLOLF@ipc.unicancer.fr
- Phone: 0491223531
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.