Malignant Distal Biliary Obstruction
Conditions
Keywords
EUS-Guided Biliary Drainage, Endoscopic retrograde cholangiopancreatography, Malignant Biliary Obstruction
Brief summary
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.
Detailed description
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.
Interventions
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
Sponsors
Indiana University
University of Colorado, Denver
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
All India Institute of Medical Sciences
Winthrop University Hospital
University of Florida
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Erasmus Medical Center
AdventHealth
Medical University of South Carolina
Institute of advanced endoscopy
Aichi Cancer Center
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institution's definition of failed procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at your institution can be considered as total of two failures. * Ability to give informed consent
Exclusion criteria
* Unable to give informed consent * Life expectancy \< 1month * Pregnant or breastfeeding women * Acute gastrointestinal bleeding * Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), or on chronic anticoagulation * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy. * Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy * ESLD with portal hypertension, varices, and/or ascites * Liver metastases burden \> 30%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness (Clinical success is defined as drop in bilirubin by 50%) | From date of intervention up to 4 weeks | Clinical success is defined as drop in bilirubin by 50% at 2 weeks and to below 3 (level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related costs | Lifetime (These patients have a life expectancy of less than 2 years) | 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) |
| Number of required procedures | From date of intervention up to death (These patients have a life expectancy of less than 2 years) | — |
| Quality of life (QOL) | From date of intervention up to 12 weeks | 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). |
| Stent patency | Lifetime (These patients have a life expectancy of less than 2 years) | Determine stent patency which is defined as time period between stent placement and need for reintervention for signs and symptoms of recurrent biliary obstruction |
| Determine safety of EGBD (Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis) | Lifetime (These patients have a life expectancy of less than 2 years) | Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis |
| Technical success | Intra- and post intervention (These patients have a life expectancy of less than 2 years) | 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 |
Countries
India, Italy, Japan, Netherlands, United States
Outcome results
None listed