View clinical trials related to Bile Duct Obstruction.
Filter by:Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain, jaundice, pruritus, leakage and/or fever. The onset of these symptoms results in hospital visits, opening of the external catheter of an internal external PTBD and re-interventions. The investigators hypothesize that daily flushing of an internal external biliary catheter will increase the time-to-symptom-onset.
Background and rationale Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents. EST may facilitate insertion of self expandable metal stent (SEMS) and also help avert the development of pancreatitis from stent-related occlusion of the pancreatic duct. On the other hand, ES is also independently associated with pancreatitis, bleeding, and perforation. Latest European guidelines indicate that EST is not necessary for inserting single plastic or metal biliary stents, nevertheless a more recent meta analysis showed that ES may decrease the rate of PEP. Population and patient selection criteria All the patient referred for endoscopic retrograde cholangiopancreatography (ERCP) due to malignant bile duct obstruction. Study design and study duration Prospective randomized, multicenter study. 18 months. Description of study treatment/product/intervention All the patients will be randomly assigned to undergo ERCP with (Group A) or without (Group B) ES before biliary SEMS placement. All the endoscopic procedures will be performed by experienced endoscopist in the endoscopy suite. All the procedure will be conducted under deep sedation. SEMS placed will be fully covered. Objectives To assess the need for EST before SEMS placement in patients with malignant bile duct obstruction. To evaluate immediate (periprocedural) and delayed (30 days) post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation. Statistical methods, data analysis A sample size analysis to detect superiority at 5% significance level and a power of 80% showed that 500 patients had to be enrolled in each group. Continuous variables such age will be reported in terms of their mean and range, and t-test will be done to test their main difference. X square test or Fisher exact test will be carried out for statistical analysis to compare rates of total complications between the two groups and rates of pancreatitis, bleeding, stent migration and perforation. Wilcoxon Mann-Withney test will be used for comparison of means between 2 continuous variables. A single-tailed P value of less than 0,05 is considered significant. Study time table Project starting date: 15-7-2015 Project completion of patients accrual: 15-10-2016 Project completion of data collection: 15-11-2016 Project data analysis: 15-2-2017 Project presentation of scientific report: 15-4-2017
Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency. RFA has showed promising results for malignant bile duct obstruction and increasing the duration of stent patency. The aim of our study was to evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.
The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.
The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months. There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction. The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.