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

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.

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%