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Biliary ObstructionBAMPINCT04595058

LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

A study testing Double pigtail plastic stent through lumen-apposing metal stent and Lumen-apposing metal stent without double pigtail plastic stent in people with Biliary Obstruction and Pancreatic Cancer, run by Hospital Universitari de Bellvitge at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Double pigtail plastic stent through lumen-apposing metal stent and Lumen-apposing metal stent without double pigtail plastic stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
2 sitesSpain
Study dates
17 Nov 2020to 17 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Double pigtail plastic stent through lumen-apposing metal stent, Lumen-apposing metal stent without double pigtail plastic stent
Keywords
Choledochoduodenostomy;, Therapeutic endoscopy, lumen apposing metal stent, biliary drainage
Medical subject headings
Pancreatic Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double pigtail plastic stent through lumen-apposing metal stentDevice

    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 stentDevice

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

Study groups in NCT04595058
Study groupRoleWhat they receive
EUSDB-LAMSActive comparatorEndoscopic 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)
Receives: Device: Lumen-apposing metal stent without double pigtail plastic stent
EUSDB-LAMS-PigtailExperimentalEndoscopic 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)
Receives: Device: Double pigtail plastic stent through lumen-apposing metal stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (Adverse events)

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

    Measured: 12 months

  2. Recurrent biliary obstruction (RBO)

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

    Measured: 12 months

Secondary outcomes (3)

  1. Clinical success

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

    Measured: 2 weeks

  2. Technical success

    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.

    Measured: 24 hours.

  3. Survival

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start17 Nov 2020
  3. Primary completion17 Oct 2022
  4. Study completion17 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595058
Sponsor's protocol ID
BAMPI
Acronym
BAMPI
Status last verified
Dec 2022
First submitted
22 Sep 2020
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Anderloni A, Fugazza A, Troncone E, Auriemma F, Carrara S, Semeraro R, Maselli R, Di Leo M, D'Amico F, Sethi A, Repici A. Single-stage EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction. Gastrointest Endosc. 2019 Jan;89(1):69-76. doi: 10.1016/j.gie.2018.08.047. Epub 2018 Sep 4.

    PubMed 30189198

  • El Chafic AH, Shah JN, Hamerski C, Binmoeller KF, Irani S, James TW, Baron TH, Nieto J, Romero RV, Evans JA, Kahaleh M. EUS-Guided Choledochoduodenostomy for Distal Malignant Biliary Obstruction Using Electrocautery-Enhanced Lumen-Apposing Metal Stents: First US, Multicenter Experience. Dig Dis Sci. 2019 Nov;64(11):3321-3327. doi: 10.1007/s10620-019-05688-2. Epub 2019 Jun 7.

    PubMed 31175495

  • Jacques J, Privat J, Pinard F, Fumex F, Chaput U, Valats JC, Cholet F, Jezequel J, Grandval P, Legros R, Lepetit H, Albouys J, Napoleon B. EUS-guided choledochoduodenostomy by use of electrocautery-enhanced lumen-apposing metal stents: a French multicenter study after implementation of the technique (with video). Gastrointest Endosc. 2020 Jul;92(1):134-141. doi: 10.1016/j.gie.2020.01.055. Epub 2020 Feb 19.

    PubMed 32084411

  • Tsuchiya T, Teoh AYB, Itoi T, Yamao K, Hara K, Nakai Y, Isayama H, Kitano M. Long-term outcomes of EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction: a prospective multicenter study. Gastrointest Endosc. 2018 Apr;87(4):1138-1146. doi: 10.1016/j.gie.2017.08.017. Epub 2017 Aug 24.

    PubMed 28843583

  • Sumalla-Garcia A, Aparicio-Tormo JR, Pedraza-Sanz R, Sanchiz-Soler V, De-la-Serna Higuera C, Andujar X, Vazquez-Sequeiros E, Puigcerver-Mas M, Martinez-Moreno B, Barbera T, Capilla-Lozano M, Martinez-Ortega A, Foruny-Olcina JR, Luna-Rodriguez D, Garcia-Lerma E, Penafiel J, Busquets Barenys J, Laquente-Saez B, Perez-Miranda M, Videla S, Loras C, Gornals JB; Spanish Working Group on Endoscopic Ultrasound Biliary Drainage. Lumen-Apposing Stents With or Without Pigtail in Endosonography-Guided Biliary Drainage for Malignant Distal Biliary Obstruction. Clin Gastroenterol Hepatol. 2026 Mar;24(3):678-687.e21. doi: 10.1016/j.cgh.2025.05.025. Epub 2025 Jul 21.

    PubMed 40701486

  • Garcia-Sumalla A, Loras C, Sanchiz V, Sanz RP, Vazquez-Sequeiros E, Aparicio JR, de la Serna-Higuera C, Luna-Rodriguez D, Andujar X, Capilla M, Barbera T, Foruny-Olcina JR, Martinez B, Dura M, Salord S, Laquente B, Tebe C, Videla S, Perez-Miranda M, Gornals JB; Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials. 2022 Feb 25;23(1):181. doi: 10.1186/s13063-022-06106-1.

    PubMed 35216619

Questions about this trial

What is this clinical trial studying?

A study testing Double pigtail plastic stent through lumen-apposing metal stent and Lumen-apposing metal stent without double pigtail plastic stent in people with Biliary Obstruction and Pancreatic Cancer, run by Hospital Universitari de Bellvitge at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (Adverse events) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04595058, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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