Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Cancer
Conditions
Keywords
Choledochoduodenostomy;, Therapeutic endoscopy, lumen apposing metal stent, biliary drainage
Brief 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.
Detailed description
The introduction of specific biliary lumen-apposing metal stents (LAMS) represented a great technical improvement in EUS-guided transmural Biliary drainage (BD) of distal malignant biliary obstruction Data is still limited, but recent studies and reviews have been reported with acceptable technical and clinical success. However, some concerns exist regarding its safety, as secondary adverse events 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 choledochoduodenostomy (CDS). Our hypothesis is that adding a coaxial plastic stent may offer benefits in terms of safety in CDS.
Interventions
DEVICEDouble 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
DEVICELumen-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
Hospital Mutua de Terrassa
Hospital del Rio Hortega
Hospital Clínico Universitario de Valencia
Hospital General Universitario de Alicante
Hospital Universitario Ramon y Cajal
Hospital Provincial de Castellon
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Adverse events) | 12 months | Safety will be measured by careful and comparative evaluation of adverse effects in both groups. |
| Recurrent biliary obstruction (RBO) | 12 months | Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | 2 weeks | Resolution of jaundice or drop in total bilirubin level by \> 50% within 2 weeks after the EUS-CD. |
| Technical success | 24 hours. | Technical success was defined as successful placement of the LAMS between the bile duct and the duodenal lumen, creating a transmural ostomy. To evaluate the correct position of the transmural stent, the deployment of the internal flap in the lumen of the bile duct must be verified by ultrasound vision and the internal flap by endoscopic vision. |
| Survival | 12 months | Survival is defined as the time elapsed between biliary drainage and the end of follow-up, either due to death and cessation of follow-up. |
Countries
Spain
Outcome results
None listed