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

NCT02103413 | Completed DMC

• 1 other identifier: EUS-BD-002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cholestasis, Extrahepatic

Outcome Measures

Primary Outcomes (1)

• Technical success of EUS-BD and PTBD

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

  twelve months

Secondary Outcomes (1)

• Complications of EUS-BD and PTBD

  twelve months

Study Arms (2)

EUS-BD

EXPERIMENTAL

EUS-BD using a fully or partially covered self-expanding metallic stent will be performed by EUS guided 19 G needle puncture.

Device: EUS-BD

PTBD

EXPERIMENTAL

PTBD with 8.5F catheter will be inserted under fluoroscopic and/or ultrasonography guidance by experienced interventional radiologists.

Device: PTBD

Interventions

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.

EUS-BD

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.

PTBD

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (2)

Tae Hoon Lee

Cheonan, South Korea

Location

Woo Hyun Paik

Ilsan, South Korea

Location

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Do Hyun Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 3, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

KR (2)