LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

Not Applicable

Completed

• Conditions: Biliary Obstruction; Biliary Tract Neoplasms; Pancreatic Cancer
• Interventions: Device: Lumen-apposing metal stent without double pigtail plastic stent; Device: Double pigtail plastic stent through lumen-apposing metal stent

• Registration Number: NCT04595058
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2020-11-17
• Primary Completion: 2022-10-17
• Status Verified: 2022-12
• Study Completion: 2023-10-17
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUSDB-LAMS	Lumen-apposing metal stent without double pigtail plastic stent	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)
EUSDB-LAMS-Pigtail	Double pigtail plastic stent through 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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain