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

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ClinicalTrials.gov Identifier: NCT04595058
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : February 17, 2021
Sponsor:
Collaborators:
Hospital Mutua de Terrassa
Hospital del Río Hortega
Hospital Clínico Universitario de Valencia
Hospital General Universitario de Alicante
Hospital Universitario Ramon y Cajal
Hospital Provincial de Castellon
Information provided by (Responsible Party):
Joan B Gornals, Hospital Universitari de Bellvitge

Study Description
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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.

Condition or disease Intervention/treatment Phase
Biliary Obstruction Pancreatic Cancer Biliary Tract Neoplasms Device: Double pigtail plastic stent through lumen-apposing metal stent Device: Lumen-apposing metal stent without double pigtail plastic stent Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized and Comparative Study of Lumen-apposing Metal Stents With or Without Coaxial Plastic Stent for Endoscopic Ultrasound-guided Transmural Biliary Drainage
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety (Adverse events) [ Time Frame: 12 months ]
    Safety will be measured by careful and comparative evaluation of adverse effects in both groups.

  2. Recurrent biliary obstruction (RBO) [ Time Frame: 12 months ]
    Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595058


Contacts
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Contact: Albert Garcia-Sumalla, MD +34676713146 albertg.sumalla@gmail.com

Locations
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Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
Contact: Joan B Gornals, MD, PhD    +34 93 260 76 82 ext 2624    jgornals@bellvitgehospital.cat   
Contact: Albert Garcia-Sumalla, MD    +34 676713146 ext 2624    albertg.sumalla@gmail.com   
Sub-Investigator: Albert Garcia-Sumalla, MD         
Sub-Investigator: Sergi Bazaga Pérez de Rozas, MD         
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Joan Gornals, MD, PhD    + 34 93 260 7682 ext 2624    jgornals@bellvitgehospital.cat   
Sub-Investigator: Albert Garcia-Sumalla, MD         
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Hospital Mutua de Terrassa
Hospital del Río Hortega
Hospital Clínico Universitario de Valencia
Hospital General Universitario de Alicante
Hospital Universitario Ramon y Cajal
Hospital Provincial de Castellon
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joan B Gornals, Head of Interventional Digestive Endoscopy Unit., Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT04595058    
Other Study ID Numbers: BAMPI
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Joan B Gornals, Hospital Universitari de Bellvitge:
Choledochoduodenostomy;
Therapeutic endoscopy
lumen apposing metal stent
biliary drainage
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Biliary Tract Diseases