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

NCT01889953 | Completed DMC

• 1 other identifier: NA_00077483
• Study Type: interventional
• Target: 96
• Locations: 5 countries
• Sites: 13

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.

Conditions

Malignant Distal Biliary Obstruction

Keywords

EUS-Guided Biliary Drainage; Endoscopic retrograde cholangiopancreatography; Malignant Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of life (QOL)

  From date of intervention up to 12 weeks

• Procedure-related costs

  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

  Intra- and post intervention (These patients have a life expectancy of less than 2 years)

• Stent patency

  Lifetime (These patients have a life expectancy of less than 2 years)

Study Arms (1)

EUS-guided biliary drainage

OTHER

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

Other: EUS-guided biliary drainage

Interventions

EUS-guided biliary drainage OTHER

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

EUS-guided biliary drainage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Johns Hopkins University: lead
• Indiana University: collaborator
• University of Colorado, Denver: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• All India Institute of Medical Sciences: collaborator
• Winthrop University Hospital: collaborator
• University of Florida: collaborator
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator
• Erasmus Medical Center: collaborator
• AdventHealth: collaborator
• Medical University of South Carolina: collaborator
• Institute of advanced endoscopy: collaborator
• Aichi Cancer Center: collaborator

Study Sites (13)

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32607, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Indiana University

Bloomington, Indiana, 47405, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

All India Institute of Medical Sciences

Delhi, 110029, India

Location

Institute of advanced endoscopy

Mumbai, 400036, India

Location

Ismett/Upmc

Palermo, 90100, Italy

Location

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Academic Medical Center of Amsterdam

Amsterdam, 1105, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3000, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 27092334 DERIVED

Study Officials

• Mouen A Khashab, MD

  Johns Hopkins Hospital Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: July 1, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 25, 2015

Record last verified: 2015-01

Locations

JP (1); IN (2); US (7); NL (2); IT (1)