EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial

Conditions
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Malignant Distal Biliary Obstruction

Intervention / Treatment
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* Other: EUS-guided biliary drainage


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EUS-guided biliary drainage<br>Patients in this arm will receive EUS-guided biliary drainage. | Other: EUS-guided biliary drainage<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From date of intervention up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | Lifetime (These patients have a life expectancy of less than 2 years) | 
| Number of required procedures |  | 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 | 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 | 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 | Lifetime (These patients have a life expectancy of less than 2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS-Guided Biliary Drainage, Endoscopic retrograde cholangiopancreatography, Malignant Biliary Obstruction