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| Name | Class |
|---|---|
| Indiana University | OTHER |
| University of Colorado, Denver | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| All India Institute of Medical Sciences |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-guided biliary drainage | Other | Patients in this arm will receive EUS-guided biliary drainage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided biliary drainage | Other | Based on the patient's condition, the will receive:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mouen A Khashab, MD | Johns Hopkins Hospital Department of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27092334 | Derived | Khashab MA, Van der Merwe S, Kunda R, El Zein MH, Teoh AY, Marson FP, Fabbri C, Tarantino I, Varadarajulu S, Modayil RJ, Stavropoulos SN, Penas I, Ngamruengphong S, Kumbhari V, Romagnuolo J, Shah R, Kalloo AN, Perez-Miranda M, Artifon EL. Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endosc Int Open. 2016 Apr;4(4):E487-96. doi: 10.1055/s-0042-102648. Epub 2016 Mar 30. |
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| OTHER |
| Winthrop University Hospital | OTHER |
| University of Florida | OTHER |
| The Mediterranean Institute for Transplantation and Advanced Specialized Therapies | OTHER |
| Erasmus Medical Center | OTHER |
| AdventHealth | OTHER |
| Medical University of South Carolina | OTHER |
| Institute of advanced endoscopy | UNKNOWN |
| Aichi Cancer Center | OTHER |
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|
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) |
| Gainesville |
| Florida |
| 32607 |
| United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Indiana University | Bloomington | Indiana | 47405 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| All India Institute of Medical Sciences | Delhi | 110029 | India |
| Institute of advanced endoscopy | Mumbai | 400036 | India |
| Ismett/Upmc | Palermo | 90100 | Italy |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| Academic Medical Center of Amsterdam | Amsterdam | 1105 | Netherlands |
| Erasmus Medical Center | Rotterdam | 3000 | Netherlands |