Malignant Distal Biliary Obstruction Clinical Trial
Official title:
EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
| Verified date | January 2015 |
| Source | Johns Hopkins University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 96 |
| Est. completion date | January 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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% |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | All India Institute of Medical Sciences | Delhi | |
| India | Institute of advanced endoscopy | Mumbai | |
| Italy | Ismett/Upmc | Palermo | |
| Japan | Aichi Cancer Center Hospital | Nagoya-shi | Aichi |
| Netherlands | Academic Medical Center of Amsterdam | Amsterdam | |
| Netherlands | Erasmus Medical Center | Rotterdam | |
| United States | University of Colorado | Aurora | Colorado |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | Indiana University | Bloomington | Indiana |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of Florida | Gainesville | Florida |
| United States | Winthrop University Hospital | Mineola | New York |
| United States | Florida Hospital | Orlando | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins University | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Aichi Cancer Center, All India Institute of Medical Sciences, New Delhi, Erasmus Medical Center, Florida Hospital, Indiana University, Institute of advanced endoscopy, Medical University of South Carolina, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, University of Colorado, Denver, University of Florida, Winthrop University Hospital |
United States, India, Italy, Japan, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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) | No |
| Secondary | Number of required procedures | From date of intervention up to death (These patients have a life expectancy of less than 2 years) | No | |
| Secondary | 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) | Yes |
| Secondary | 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) | Yes |
| Secondary | 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) | Yes |