LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2023-10-17

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.

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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.

Conditions

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Biliary Obstruction Pancreatic Cancer Biliary Tract Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EUSDB-LAMS

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)

Group Type ACTIVE_COMPARATOR

Lumen-apposing metal stent without double pigtail plastic stent

Intervention Type DEVICE

Endoscopic ultrasound-guided transmural biliary drainage is with lumen-apposing metal stent is a formal indication according to the instruction forms of the manufacturer.

EUSDB-LAMS-Pigtail

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)

Group Type EXPERIMENTAL

Double pigtail plastic stent through lumen-apposing metal stent

Intervention Type DEVICE

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

Interventions

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Double 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

Intervention Type DEVICE

Lumen-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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Distal biliary strictures,
* A prior failed attempt at biliary drainage
* informed consent provided by the patient.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No