Skip to main content
OpenTrials
Completed

NCT Number: NCT02103413

EUS-guided Biliary Drainage Versus Percutanenous Transhepatic Biliary Darinage for Malignant Biliary Obstruction After Failed ERCP

Although ERCP is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients.

Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery.

Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.10-21 There has been no comparative study between the outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications.

The researchers investigated the technical success of EUS-BD and PTBD in patients with malignant biliary obstruction after failed conventional ERCP as a prospective randomized comparative study in multicenters. Secondary endpoints were the cost-effectiveness and complications rates between EUS-BD and PTBD.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tae Hoon Lee, Cheonan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of unresectable malignant distal biliary obstruction (greater 2cm than distal to hilum, i.e., pancreatic cancer, common bile duct cancer, ampulla of Vater cancer, gallbladder cancer, duodenal cancer, and metastatic biliary obstruction)
  • Failed conventional ERCP and inaccessible papilla because of accompanying duodenal obstruction, periampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation.)
  • Histologic or cytologic diagnosis of malignancy, d) A Karnofsky index of ≧30%, e) No serious or uncontrolled medical illness
  • Provided informed consent.

Exclusion criteria

  • patient age of less than 18 years
  • uncorrectable coagulopathy
  • history of allergy to radiocontrast agents
  • refusal to participate in this study.

Treatment and study plan

EUS-BD

Device

When the ERCP was unsuccessful, we tried one-step EUS-BDS using a linear-array echoendoscope (GF-UCT 240-AL 10 or AL 5, Olympus Medical Systems, Tokyo, Japan) at the same ERCP unit on the same session. EUS-BDS was performed by EUS-guided choledocoduodeostomy (EUS-CD) or EUS-guided hepaticogastrostomy (EUS-HG) at the discretion of involved endosonographers. Based on our modified protocol from two our proposed protocols, EUS-BD with transmural stenting was only considered.

PTBD

Device

PTBD was performed in selected patients with an 8.5F catheter inserted under fluoroscopic or ultrasound guidance by experienced interventional radiologists or endoscopists.

Primary outcomes

  1. Technical success of EUS-BD and PTBD

    Time frame: twelve months

    Technical success rate of EUS-BD and PTBD after failed ERCP

Secondary outcomes

  1. Complications of EUS-BD and PTBD

    Time frame: twelve months

    Complications rate of EUS-BD and PTBD in patients who failed ERCP

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Multicenter Study of EUS-guided Biliary Drainage Versus Percutanenous Transhepatic Biliary Darinage for Malignant Biliary Obstruction After Failed ERCP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2014
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.