The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) with a biliary lumen-apposing metal stent (LAMS) has been widely accepted as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). Recent studies (DRAMBO and ELEMENT trial) compared EUS-CDS vs ERCP as a first line treatment in MDBO in palliative patients, showing similar clinical and techinal success and adverse events rate between both techniques, demonstrating that both procedures could be options for primary biliary drainage in unresectable MDBO. Furthermore a recent clinical trial (BAMPI trial) has proven that the addition of a coaxial double pigtail (DPS) offers benefits in terms of safey and clinical success. In the last years there has been an increasing interest for the EUS-guided gallblader drainage (EUS-GBD) in unresectable MDBO as an alternative for EUS-CDS, and recent studies and reviews have been reported with acceptable techinal and clinical success, but no clinical trial has been performed up to date. Our hypothesis is that EUS-GBD may offer benefits in terms of safety over EUS-CDS, maintaining similar clinical and techinal success rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
Decompression of the bile duct by endoscopic aproach.
Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader. * DPPS size: 7Fr x 3-5-7cm.
Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \> 18mm. * DPPS size: 7Fr x 3-7cm.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, Spain
RECRUITINGHospital General Alicante
Alicante, Valencia, Spain
RECRUITINGRELATED ADVERSE EVENTS
Safety will be measured by careful and comparative evaluation of adverse effects in both groups.
Time frame: 12 months
Patients with Recurrent biliary obstruction
Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.
Time frame: 12 months
CLINICAL SUCCESS
Resolution of jaundice or drop in total bilirubin level by \> 50% within 2 weeks after the EUS guided drainage.
Time frame: 2 weeks
TECHNICAL SUCCESS
Technical success was defined as successful placement of the LAMS between the bile duct (choledoc or gallblader) and the lumen digestive system (stomach or duodenum), 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.
Time frame: 24 hours
BILIARY REINTERVENTIONS (BRI)
Interventions needed to treat - Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.
Time frame: 12 months
HOSPITAL STAY
Length of hospital stay after intervention
Time frame: 12 months
MORTALITY
Overall mortality throughout the study
Time frame: 12 months
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Hospital Universitari de Castello
Castellon, Valencia, Spain
Hospital Santa Creu I Sant Pau
Barcelona, Spain
ACTIVE_NOT_RECRUITINGHospital Virgen de Las Nieves
Granada, Spain
NOT_YET_RECRUITINGComplejo Hospitalario de Pamplona
Pamplona, Spain
ACTIVE_NOT_RECRUITINGHospital Santiago de Compostela
Santiago de Compostela, Spain
ACTIVE_NOT_RECRUITINGHospital Mutua de Terrassa
Terrassa, Spain
RECRUITINGHospital Clinic de Valencia
Valencia, Spain
NOT_YET_RECRUITINGHospital Cunqueiro de Vigo
Vigo, Spain
ACTIVE_NOT_RECRUITINGCOST ANALYSIS
Evaluate the costs between the two types of strategy
Time frame: 12 months