Abstract
BackgroundEndoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency. Although the expected patency of SEMS is around 8 months, it has recently been reported that the duration of SEMS’ patency in patients using aspirin is prolonged. Our study, therefore, aims to investigate the effect of aspirin on SEMS’ patency.Methods/designThis is an investigator-initiated, prospective, multicenter, double-blind, randomized placebo-controlled trial that will be conducted from November 2017 in four tertiary centers in South Korea. We intend to include in our study 184 adult (aged ≥ 20 years) patients with malignant distal CBD obstruction for whom ERBD with SEMS was successfully performed. The patients will be randomly allocated to two groups, which will comprise patients who have either taken 100 mg aspirin or a placebo for 6 months after index ERBD. The primary outcome will be the rate of stent dysfunction, and the secondary outcomes will be the duration of patency, the rate of reintervention, and the occurrence of adverse events.DiscussionThe aspirin for metal stents in malignant distal common bile duct obstruction (AIMS) study should determine the efficacy of aspirin in maintaining metal-stent patency in patients with malignant distal CBD obstructive.Trial registrationClinicalTrials.gov, ID: NCT03279809. Registered on 5 September 2017.
Highlights
Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction
The aspirin for metal stents in malignant distal common bile duct obstruction (AIMS) study should determine the efficacy of aspirin in maintaining metal-stent patency in patients with malignant distal CBD obstructive
Endoscopic biliary drainage for malignant distal common bile duct (CBD) obstruction is the modality of choice that could resolve multiple clinical problems for patients with conditions such as jaundice, pain, sepsis, and organ failure
Summary
Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Several studies, including a metaanalysis, have reported that self-expandable metal stents (SEMS) have advantages over plastic stents in terms of stent patency, adverse events, revisions, and the survival of patients with malignant biliary obstruction [1,2,3,4,5,6,7]. SEMS do not maintain patency for long periods within an overall life span because the stent may become obstructed due to, predominantly, tumor ingrowth or overgrowth, sludge deposition, biofilm formation, or epithelial hyperplasia [8,9,10]. Some of these factors may be affected by aspirin when considering the. The use of systemic drugs, including ursodeoxycholic acid (UDCA) and antibiotics, to effectively prevent stent dysfunction, has not been reported [12]
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