Trials / Completed
CompletedNCT04420039
Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction
Is Useful a Coaxial Plastic Stent Within a Lumen-Apposing Metal Stent For The Palliative Management Of Malignant Biliary Obstruction?
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 39 (actual)
- Sponsor
- Hospital Universitari de Bellvitge · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endoscopic biliary transmural drainage | Endosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction. Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent. |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2020-09-01
- Completion
- 2021-03-01
- First posted
- 2020-06-09
- Last updated
- 2021-07-13
Locations
3 sites across 1 country: Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04420039. Inclusion in this directory is not an endorsement.