LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter, Randomized and Comparative Study of Lumen-apposing Metal Stents With or Without Coaxial Plastic Stent for Endoscopic Ultrasound-guided Transmural Biliary Drainage

Conditions
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Biliary Obstruction, Pancreatic Cancer, Biliary Tract Neoplasms

Intervention / Treatment
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* Device: Double pigtail plastic stent through lumen-apposing metal stent
* Device: Lumen-apposing metal stent without double pigtail plastic stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUSDB-LAMS<br>Endoscopic ultrasound-guided choledochoduodenostomy with lumen-apposing metal stent . Formal indication on biliopancreatic drainage according to the instruction forms of the manufacturer. EUSDB-LAMS (Endoscopic ultrasound guided biliary drainage with lumen-apposing metal stent) | Device: Lumen-apposing metal stent without double pigtail plastic stent<br>* Endoscopic ultrasound-guided transmural biliary drainage is with lumen-apposing metal stent is a formal indication according to the instruction forms of the manufacturer.<br>|
| Experimental: EUSDB-LAMS-Pigtail<br>Endoscopic ultrasound-guided choledochoduodenostomy with lumen-apposing metal stents without coaxial plastic stent. Formal indication on biliopancreatic drainage according to the instruction forms of the manufacturer. In this arm, a double pigtail through the lumen apposing metal stent will be inserted as an axis-orienting stent. EUSDB-LAMS-Pigtial (Endoscopic ultrasound guided biliary drainage with lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent through LAMS) | Device: Double pigtail plastic stent through lumen-apposing metal stent<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse events) | Safety will be measured by careful and comparative evaluation of adverse effects in both groups. | 12 months | 
| Recurrent biliary obstruction (RBO) | Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Resolution of jaundice or drop in total bilirubin level by > 50% within 2 weeks after the EUS-CD. | 2 weeks | 
| Technical success | 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. | 24 hours. | 
| Survival | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choledochoduodenostomy;, Therapeutic endoscopy, lumen apposing metal stent, biliary drainage