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

Not Applicable

Completed

• Conditions: Malignant Distal Biliary Obstruction
• Interventions: Other: EUS-guided biliary drainage

• Registration Number: NCT01889953
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-07-01
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-guided biliary drainage	EUS-guided biliary drainage	Patients in this arm will receive EUS-guided biliary drainage.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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)
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
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
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

Trial Locations

Locations (13)

Institute of advanced endoscopy; 🇮🇳 Mumbai, India

All India Institute of Medical Sciences; 🇮🇳 Delhi, India

University of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Indiana University; 🇺🇸 Bloomington, Indiana, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Ismett/Upmc; 🇮🇹 Palermo, Italy

Aichi Cancer Center Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Academic Medical Center of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands