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NCT04405752: BIGDIAM
Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study
trial testing 12-mm metallic biliary stent in Malignant Biliary Obstruction in 72 participants. Completed in 1 April 2018.
1 April 2018
Quick facts
| Lead sponsor | Institut Paoli-Calmettes |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 72 |
| Start date | 1 April 2017 |
| Primary completion | 1 April 2018 |
| Estimated completion | 1 April 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- 12-mm metallic biliary stent
- 10-mm metallic biliary stent
Conditions studied
- Malignant Biliary Obstruction — all drugs for Malignant Biliary Obstruction →
Sponsor
Institut Paoli-Calmettes — full company profile →
Who can join
18 and older, any sex, with Malignant Biliary Obstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04405752
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Malignant Biliary Obstruction
Currently open trials in the same condition.
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- NCT05169398 — EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent · NA · recruiting
Other Institut Paoli-Calmettes trials
Trials by the same sponsor.
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- NCT06055621 — Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE · Phase 2 · recruiting
- NCT05986071 — I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04405752 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Paoli-Calmettes
- Last refreshed: 28 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04405752.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing