Clinical trial NCT01889953: EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
Official title: EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Distal Biliary Obstruction
Keywords: EUS-Guided Biliary Drainage
Endoscopic retrograde cholangiopancreatography
Malignant Biliary Obstruction
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Indiana University
name: University of Colorado, Denver
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: All India Institute of Medical Sciences
name: Winthrop University Hospital
name: University of Florida
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: Erasmus Medical Center
name: AdventHealth
name: Medical University of South Carolina
name: Institute of advanced endoscopy
name: Aichi Cancer Center
First posted: 2013-07-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Effectiveness (Clinical success is defined as drop in bilirubin by 50%)
timeFrame: From date of intervention up to 4 weeks
Secondary outcomes:
measure: Quality of life (QOL)
timeFrame: From date of intervention up to 12 weeks
measure: Procedure-related costs
timeFrame: Lifetime (These patients have a life expectancy of less than 2 years)
measure: Number of required procedures
timeFrame: From date of intervention up to death (These patients have a life expectancy of less than 2 years)
measure: Technical success
timeFrame: Intra- and post intervention (These patients have a life expectancy of less than 2 years)
measure: Stent patency
timeFrame: Lifetime (These patients have a life expectancy of less than 2 years)
measure: Determine safety of EGBD (Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis)
timeFrame: Lifetime (These patients have a life expectancy of less than 2 years)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Delhi
country: India
facility: All India Institute of Medical Sciences
city: Mumbai
country: India
facility: Institute of advanced endoscopy
city: Palermo
country: Italy
facility: Ismett/Upmc
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Amsterdam
country: Netherlands
facility: Academic Medical Center of Amsterdam
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Johns Hopkins Hospital Department of Gastroenterology
name: Mouen A Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.