LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent (BAMPI)

Catalan Institute of Health

Status: Completed

Conditions: Biliary Tract Neoplasms; Biliary Obstruction; Pancreatic Cancer

Treatments: Device: Lumen-apposing metal stent without double pigtail plastic stent; Device: Double pigtail plastic stent through lumen-apposing metal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT04595058

BAMPI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

EUSDB-LAMS

Active Comparator group

Description:

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)

Treatment:

Device: Lumen-apposing metal stent without double pigtail plastic stent

EUSDB-LAMS-Pigtail

Experimental group

Description:

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)

Treatment:

Device: Double pigtail plastic stent through lumen-apposing metal stent