Clinical trial NCT04595058: LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Obstruction
Pancreatic Cancer
Biliary Tract Neoplasms
Keywords: Choledochoduodenostomy;
Therapeutic endoscopy
lumen apposing metal stent
biliary drainage
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
name: Hospital del Rio Hortega
name: Hospital Clínico Universitario de Valencia
name: Hospital General Universitario de Alicante
name: Hospital Universitario Ramon y Cajal
name: Hospital Provincial de Castellon
First posted: 2020-10-20
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Safety (Adverse events)
timeFrame: 12 months
measure: Recurrent biliary obstruction (RBO)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical success
timeFrame: 2 weeks
measure: Technical success
timeFrame: 24 hours.
measure: Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona, Catalonia
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.