LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

NCT04595058 | Completed DMC FDA Device

• 1 other identifier: BAMPI
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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.

Conditions

Biliary Obstruction; Pancreatic Cancer; Biliary Tract Neoplasms

Keywords

Choledochoduodenostomy;; Therapeutic endoscopy; lumen apposing metal stent; biliary drainage

Outcome Measures

Primary Outcomes (2)

• Safety (Adverse events)

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

  12 months

• Recurrent biliary obstruction (RBO)

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

  12 months

Secondary Outcomes (3)

• Clinical success

  2 weeks

• Technical success

  24 hours.

• Survival

  12 months

Study Arms (2)

EUSDB-LAMS

ACTIVE COMPARATOR

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

EUSDB-LAMS-Pigtail

EXPERIMENTAL

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

Interventions

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

EUSDB-LAMS-Pigtail

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.

EUSDB-LAMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Distal biliary strictures,
• A prior failed attempt at biliary drainage
• informed consent provided by the patient.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Hospital Mutua de Terrassa: collaborator
• Hospital del Rio Hortega: collaborator
• Hospital Clínico Universitario de Valencia: collaborator
• Hospital General Universitario de Alicante: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Provincial de Castellon: collaborator

Study Sites (2)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (6)

• 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.

  PMID: 30189198 BACKGROUND

• 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.

  PMID: 31175495 RESULT

• 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.

  PMID: 32084411 RESULT

• 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.

  PMID: 28843583 RESULT

• 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. 2025 Jul 21:S1542-3565(25)00611-1. doi: 10.1016/j.cgh.2025.05.025. Online ahead of print.

  PMID: 40701486 DERIVED

• 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. Erratum In: Trials. 2022 Mar 14;23(1):214. doi: 10.1186/s13063-022-06138-7.

  PMID: 35216619 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interventional Digestive Endoscopy Unit.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 20, 2020
• Study Start: November 17, 2020
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2023
• Last Updated: April 18, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)