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

NCT ID: NCT01889953

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-01-31

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.

Conditions

Malignant Distal Biliary Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EUS-guided biliary drainage

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

Group Type: OTHER

EUS-guided biliary drainage

Intervention Type: 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

Interventions

EUS-guided biliary drainage

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

Intervention Type: OTHER

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

Winthrop University Hospital

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: collaborator

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

AdventHealth

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Institute of advanced endoscopy

UNKNOWN

Sponsor Role: collaborator

Aichi Cancer Center

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Mouen Khashab

Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mouen A Khashab, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Hospital Department of Gastroenterology

Locations

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

All India Institute of Medical Sciences

Delhi, , India

Institute of advanced endoscopy

Mumbai, , India

Ismett/Upmc

Palermo, , Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Academic Medical Center of Amsterdam

Amsterdam, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Countries

United States; India; Italy; Japan; Netherlands

References

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.

Reference Type: DERIVED

PMID: 27092334 (View on PubMed)

Other Identifiers

NA_00077483

Identifier Type: -

Identifier Source: org_study_id