CompletedNot Applicable

LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

Spain123 participantsStarted 2020-11-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Distal biliary strictures, * A prior failed attempt at biliary drainage * informed consent provided by the patient. Patient exclusion criteria were as follows: * younger than age 18 years, * coagulopathy (international normalized ratio \>1.5, marked thrombocytopenia with a platelet count \<50,000/mL, or patient on anticoagulation therapy), * critical illness.

What they're measuring

Safety (Adverse events)

Timeframe: 12 months

Recurrent biliary obstruction (RBO)

Timeframe: 12 months

Trial details

NCT IDNCT04595058

SponsorHospital Universitari de Bellvitge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-17

View on ClinicalTrials.gov More Biliary Obstruction trials