The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in potentially surgical patients is still limited. Recent retrospective study (Janet J et al, Ann Surg Oncol 2023) and two recent meta-analysis (Barbosa E et al, GIE 2024; Gopakumar H et al, AM J Gastr 2024; both with \> 500 cases) found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate. Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates (technical failure, postprocedure pancreatitis) when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Decompression of the bile duct by endoscopic aproach.
Self-expandable metallic stent (SEMS) deployment: Covering: Uncovered or Partially Covered. Non covered if gallbladder is present. Size: 10x40mm or 10x60mm or 10x80mm.
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 General Universitario Dr. Balmis
Alicante, Alicante, Spain
NOT_YET_RECRUITINGHospital General Universitario de Castellón
Castellon, Castellón, Spain
NOT_YET_RECRUITINGPostprocedure surgical challenges rate
Percentage of biliary drainage technical failure and/or percentage of postprocedure acute pancreatitis.
Time frame: 1 day to 24 months
Clinical success
In jaundice: decreasing \> 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure.
Time frame: 14 days after BD
AE - biliary drainage
Adverse events rate related to biliary drainage according to the AGREE classification
Time frame: 0 to 30 days after BD
AE - surgery
Adverse events rate related to surgery according to the Claiven and Dindo classification.
Time frame: 0 to 90 days after surgery
Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)
Number of days between intervention (T1-biliary drainage) and surgery
Time frame: 1 day to 6 months
Rate of surgery
Rate of patients that undergo to surgery
Time frame: 1 to 24 months
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Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain
NOT_YET_RECRUITINGHospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Catalonia, Spain
RECRUITINGHospital Mútua de Terrassa
Terrassa, Catalonia, Spain
RECRUITINGHospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
NOT_YET_RECRUITINGHospital Universitario Virgen de las Nieves
Granada, Granada, Spain
NOT_YET_RECRUITINGComplejo Hospitalario de Navarra
Pamplona, Navarre, Spain
NOT_YET_RECRUITINGHospital Clínico Universitario de Salamanca
Salamanca, Salamanca, Spain
NOT_YET_RECRUITINGHospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
NOT_YET_RECRUITING