Evaluating the effectiveness of uncovered duodenal prostheses for treating duodenal stenosis
Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille, Bouches Du Rhone) |
| Trial ID | NCT03463668 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with benign stenosis or those who have received covered metallic duodenal prostheses will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Marseille, Bouches Du Rhone
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.