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Completed

NCT Number: NCT04595058

LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

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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Key information

Conditions

Biliary Obstruction Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Double pigtail plastic stent through lumen-apposing metal stent

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

Lumen-apposing metal stent without double pigtail plastic stent

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BAMPI

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 20, 2020
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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