LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent (BAMPI)
Biliary Obstruction, Pancreatic Cancer, Biliary Tract Neoplasms
About this trial
This is an interventional treatment trial for Biliary Obstruction focused on measuring Choledochoduodenostomy;, Therapeutic endoscopy, lumen apposing metal stent, biliary drainage
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitari de Bellvitge
- Hospital Universitari de Bellvitge
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
EUSDB-LAMS
EUSDB-LAMS-Pigtail
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)
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)