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LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

NCT04595058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2024-04-18

No results posted yet for this study

Summary

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with and without a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies (CDS) for the management of biliary obstruction.

Conditions

Interventions

DEVICE

Double pigtail plastic stent through lumen-apposing metal stent

Biliary drainage guided by endoscopic ultrasound: Addition or not, of a axis-orienting plastic stent, mostly, double-pigtail stent through the lumen of a lumen-apposing metal stent

DEVICE

Lumen-apposing metal stent without double pigtail plastic stent

Endoscopic ultrasound-guided transmural biliary drainage is with lumen-apposing metal stent is a formal indication according to the instruction forms of the manufacturer.

Sponsors & Collaborators

  • Hospital Mutua de Terrassa

    collaborator OTHER

  • Hospital del Rio Hortega

    collaborator OTHER

  • Hospital Clínico Universitario de Valencia

    collaborator OTHER

  • Hospital General Universitario de Alicante

    collaborator OTHER

  • Hospital Universitario Ramon y Cajal

    collaborator OTHER

  • Hospital Provincial de Castellon

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2022-10-17
Completion
2023-10-17
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 NCT04595058 on ClinicalTrials.gov