The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline 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 borderline patients is still limited. A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included borderline patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer endoscopy and surgery AEs. Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in borderline patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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 Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Delay in days between endoscopic biliary drainage and chemotherapy treatment start
Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.
Time frame: 1 day to 12 months
Technical success
ERCP group: cannulation, cholangiogram, correct deployment of SEMS
Time frame: day 0
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: 6 to 12 months
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