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

April 16, 2024 updated by: Joan B Gornals, Hospital Universitari de Bellvitge

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
    • Barcelona, Catalonia
      • L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
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.
Experimental: 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)
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (Adverse events)
Time Frame: 12 months
Safety will be measured by careful and comparative evaluation of adverse effects in both groups.
12 months
Recurrent biliary obstruction (RBO)
Time Frame: 12 months
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
Time Frame: 2 weeks
Resolution of jaundice or drop in total bilirubin level by > 50% within 2 weeks after the EUS-CD.
2 weeks
Technical success
Time Frame: 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.
24 hours.
Survival
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Collaborators

Hospital Universitario Ramon y Cajal
Hospital Mutua de Terrassa
Hospital del Rio Hortega
Hospital Provincial de Castellon
Hospital General Universitario de Alicante
Hospital Clínico Universitario de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

October 17, 2022

Study Completion (Actual)

October 17, 2023

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAMPI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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