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Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction

NCT04420039 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2021-07-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital Mutua de Terrassa

    collaborator OTHER

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER

  • Institut d'Investigació Biomèdica de Bellvitge

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-09-30
Completion
2021-03-31
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420039 on ClinicalTrials.gov