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BAMPI: LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

Sponsor
Hospital Universitari de Bellvitge (Other)
Overall Status
Recruiting
CT.gov ID
NCT04595058
Collaborator
Hospital Mutua de Terrassa (Other), Hospital del Río Hortega (Other), Hospital Clínico Universitario de Valencia (Other), Hospital General Universitario de Alicante (Other), Hospital Universitario Ramon y Cajal (Other), Hospital Provincial de Castellon (Other)
60
Enrollment
2
Locations
2
Arms
23.5
Anticipated Duration (Months)
30
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Double pigtail plastic stent through lumen-apposing metal stent
  • Device: Lumen-apposing metal stent without double pigtail plastic stent
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Nov 17, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Safety (Adverse events) [12 months]

    Safety will be measured by careful and comparative evaluation of adverse effects in both groups.

  2. Recurrent biliary obstruction (RBO) [12 months]

    Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.

Secondary Outcome Measures

  1. Clinical success [2 weeks]

    Resolution of jaundice or drop in total bilirubin level by > 50% within 2 weeks after the EUS-CD.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona, Catalonia Spain 08907
2 Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona Spain 08907

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Oct 20, 2020
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Head of Interventional Digestive Endoscopy Unit., Hospital Universitari de Bellvitge
Choledochoduodenostomy;
Therapeutic endoscopy
lumen apposing metal stent
biliary drainage
Additional relevant MeSH terms:
Biliary Tract Neoplasms

Study Results

No Results Posted as of Feb 17, 2021