RESUMO
BACKGROUND AND AIMS: Endoscopic ultrasound-guided pancreatic duct intervention (EUS-PDI) is one of the most technically challenging procedures. There remains a knowledge gap due to its rarity. The aim is to report the accumulated EUS-PDI experience in a tertiary center. METHODS: Single-tertiary center, retrospective cohort study of prospectively collected data during the study period, from Jan 2013-June 2021. RESULTS: In total, 14 patients (85% male; mean age, 61years, range:37-81) and 25 EUS-PDI procedures for unsuccessful endoscopic retrograde pancreatography (ERP) were included. Principal etiology was chronic pancreatitis with pancreatic duct obstruction (78%). EUS-guided assisted (colorant and/or guidewire, rendezvous) ERP was performed in 14/25(56%); and transmural drainage in 11procedures, including pancreaticogastrosmy in 9/25(36%) and pancreaticoduodenostomy in 2/25(8%). Overall technical and clinical success was 78.5%(11/14). Three (21%) patients required a second procedure with success in all cases. Two failed cases required surgery. Three (21%) adverse events(AEs) were noted (fever, n=1; perforation n=1; pancreatitis n=1). Patients underwent a median of 58months (range 24-108) follow-up procedures for re-stenting. Spontaneous stent migration was detected in 50% of cases. CONCLUSIONS: EUS-PDI is an effective salvage therapy for unsuccessful ERP, although 21% of patients may still experience AEs. In case of EUS-guided rendezvous failure, it can cross over to a transmural drainage.
RESUMO
BACKGROUND: It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. METHODS/DESIGN: This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). DISCUSSION: The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction. TRIAL REGISTRATION: ClinicalTrials.gov NCT04595058 . Registered on October 14, 2020.