An interventional study of EUS-guided biliary drainage in Malignant Distal Biliary Obstruction, sponsored by Johns Hopkins University. Completed at 13 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-25.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
This research is being done to study the safety and feasibility of recruiting patients eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety and effectiveness of this procedure.
Our central hypothesis is that EGBD is equally effective and safe to percutaneous transhepatic biliary drainage (PTBD) but is associated with better quality of life than PTBD in patients with inoperable malignant distal biliary obstruction who have failed prior ERCP. Furthermore, EGBD may be associated with decreased procedure-related costs. Patients who undergo PTBD usually require multiple procedures for stent exchange/upsize. Our initial study will be a prospective multicenter feasibility study that will include patients with inoperable distal biliary obstruction who have failed ERCP. If feasibility is demonstrated, our goal will be to compare EGBD and PTBD in a randomized multicenter international trial with a crossover design.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will receive EUS-guided biliary drainage.
Other: EUS-guided biliary drainage
Based on the patient's condition, the will receive: * Rendezvous technique * Direct transluminal access transesophageal technique * Direct transluminal access transduodenal technique * or direct transluminal access using transgastric approach
Effectiveness (Clinical success is defined as drop in bilirubin by 50%)
Clinical success is defined as drop in bilirubin by 50% at 2 weeks and to below 3 (level
Time frame: From date of intervention up to 4 weeks
Quality of life (QOL)
Determine improvement in QOL of patients after PTBD. QOL will be assessed using the EORTC-QLQ-30 instrument (at baseline, 1 week, 4 weeks and 12 weeks after the procedure).
Time frame: From date of intervention up to 12 weeks
Procedure-related costs
Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of PTBD in case of failed EGBD, cost of managing complications, cost of reintervention in case of stent occlusion, etc)
Time frame: Lifetime (These patients have a life expectancy of less than 2 years)
Number of required procedures
Time frame: From date of intervention up to death (These patients have a life expectancy of less than 2 years)
Technical success
This is defined as success of stent placement in the desired location as determined endoscopically and radiographically. In addition, success of each step during EUS will be tracked and recorded (e.g. needle puncture, cholangiography, tract dilation, etc
Time frame: Intra- and post intervention (These patients have a life expectancy of less than 2 years)
Stent patency
Determine stent patency which is defined as time period between stent placement and need for reintervention for signs and symptoms of recurrent biliary obstruction
Time frame: Lifetime (These patients have a life expectancy of less than 2 years)
Determine safety of EGBD (Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis)
Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis
Time frame: Lifetime (These patients have a life expectancy of less than 2 years)
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University