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

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Johns Hopkins University

Status

Completed

Conditions

Malignant Distal Biliary Obstruction

Treatments

Other: EUS-guided biliary drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT01889953
NA_00077483

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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%

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

96 participants in 1 patient group

EUS-guided biliary drainage
Other group
Description:
Patients in this arm will receive EUS-guided biliary drainage.
Treatment:
Other: EUS-guided biliary drainage

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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