Background Information

CRIS Registration Number	KCT0001370
Unique Protocol ID	SCHCA 2014-01-019
Public/Brief Title	The efficacy of endoscopic ultrasonography-guided biliary drainage versus percutaneous transhepatic biliary drainage in patients with failed biliary cannulation of malignant biliary obstructions
Scientific Title	The efficacy of endoscopic ultrasonography-guided biliary drainage versus percutaneous transhepatic biliary drainage in patients with failed biliary cannulation of malignant biliary obstructions; A prospective multicenter study
Acronym	DEUS STUDY
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	Yes
Name of Registry/ Registration Number
Healthcare Benefit Approval Status

Institutional Review Board Information

Board Approval Status	Submitted approval
Board Approval Number	SCHCA201401019002
Approval Date	2014-02-05
Institutional Review Board
- Name	The Institutional Review Board at the University of Soonchunhyang Medical Center
- Address
- Telephone
Data Monitoring Committee	Yes The Institutional Review Board at the University of Soonchunhyang University

Contact Details

Contact Person for Principal Investigator / Scientific Queries
- Name	Do Hyun Park
- Title	MD, PhD
- Telephone	+82-2-3010-3180
- Affiliation	Asan Medical Center
- Address	388-1 Poongnap-dong, Songpa-gu, Seoul, Korea
Contact Person for Public Queries
- Name	Tae Hoon Lee
- Title	MD, PhD
- Telephone	+82-41-570-3662
- Affiliation	Soon Chun Hyang University Hospital Cheonan
- Address	Soonchunhyang 6-gil 31, Dongnamgu, Cheonan
Contact Person for Updating Information
- Name	Tae Hoon Lee
- Title	MD, PhD
- Telephone	+82-41-570-3662
- Affiliation	Soon Chun Hyang University Hospital Cheonan
- Address	Soonchunhyang 6-gil 31, Dongnamgu, Cheonan

Status

Study Site	Multi-center (Number of center : 4)
Overall Recruitment Status	Completed
Date of First Enrollment	2014-10-06 , Actual
Target Number of Participant	68
Primary Completion Date	2015-04-30 , Actual
Study Completion Date	2015-07-31 , Actual
Recruitment Status by Participating Study Site 1
- Name of Study Site	Asan Medical Center
- Recruitment Status	Completed
- Date of First Enrollment	2014-10-06 , Actual
Recruitment Status by Participating Study Site 2
- Name of Study Site	Soon Chun Hyang University Hospital Cheonan
- Recruitment Status	Completed
- Date of First Enrollment	2014-10-06 , Actual
Recruitment Status by Participating Study Site 3
- Name of Study Site	Pusan National University Hospital
- Recruitment Status	Completed
- Date of First Enrollment	2014-11-24 , Actual
Recruitment Status by Participating Study Site 4
- Name of Study Site	Dankook Univeristy Hospital
- Recruitment Status	Completed
- Date of First Enrollment	2014-11-19 , Actual

Source of Monetary / Material Support 정보

Source of Monetary/Material Support1
- Organization Name	Ministry of Health & Welfare
- Organization Type	Government
- Project ID	HI14C0139

Sponsor Organization

Sponsor Organization 1
- Organization Name	Asan Medical Center
- Organization Type	Medical Institute

Study Summary

Lay 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.

Study Design 정보

Study Type		Interventional Study
Study Purpose		Treatment
Phase		Not applicable
Intervention Model		Parallel
Blinding/Masking		Single
Blinded Subject		Subject
Allocation		RCT
Intervention Type		Medical Device, /Procedure/Surgery
Intervention Description		EUS-guided hepaticogastrostomy (EUS-HG) will be performed in patients with hilar stricture or altered anatomy such as Roux-en-Y anastomosis, and EUS-guided choledochoduodenostomy (EUS-CD) will be performed in patients with mid to distal extrahepatic bile duct strictures. Because EUS-guided rendezvous technique can be attempted only in patients in whom the papilla is endoscopically accessible. Following bile duct puncture using a 19-gauge fine needle, one-step or graded tract dilatation will be performed. Then, finally we insert a partially or fully covered metallic stent. PTBD was performed in selected patients with an 8.5F catheter inserted under fluoroscopic or ultrasound guidance by experienced interventional radiologists or endoscopists.
Number of Arms		2
Arm 1	Arm Label	Percutaneous transhepatic biliary drainage
	Target Number of Participant	34
	Arm Type	Active comparator
	Arm Description	PTBD was performed in selected patients with an 8.5F catheter inserted under fluoroscopic or ultrasound guidance by experienced interventional radiologists or endoscopists.
Arm 2	Arm Label	Endoscopic ultrasonography-guided biliary drainage
	Target Number of Participant	34
	Arm Type	Experimental
	Arm Description	EUS-guided hepaticogastrostomy (EUS-HG) will be performed in patients with hilar stricture or altered anatomy such as Roux-en-Y anastomosis, and EUS-guided choledochoduodenostomy (EUS-CD) will be performed in patients with mid to distal extrahepatic bile duct strictures. Because EUS-guided rendezvous technique can be attempted only in patients in whom the papilla is endoscopically accessible. Following bile duct puncture using a 19-gauge fine needle, one-step or graded tract dilatation will be performed. Then, finally we insert a partially or fully covered metallic stent.

Subject Eligibility Information

Condition(s)/Problem(s)		* Diseases of the digestive system
Rare Disease		No
Inclusion Criteria	Gender	Both
	Age	19 Year ~ No Limit
	Description	a) the presence of an unresectable malignant distal biliary obstruction (greater than 2 cm distal to the hilum); b) failed conventional ERCP and inaccessible papilla because of accompanying duodenal obstruction, periampullary tumor infiltration, or surgically altered anatomy; c) histologic or cytologic diagnosis of malignancy; d) a Karnofsky index of ≧30%; e) no serious or uncontrolled medical illnesses; and f) provision of informed consent.
Exclusion Criteria		a) patient age of less than 18 years, b) hilar biliary obstruction, c) uncorrectable coagulopathy, d) a history of allergies to radiocontrast agents, and e) refusal to participate in this study.
Healthy Volunteers		No

Outcome Measure(s) Information

Type of Primary Outcome	Efficacy
Primary Outcome(s) 1
- Outcome	Technical success of EUS-BD and PTBD
- Timepoint	After completion of intervention
Secondary Outcome(s) 1
- Outcome	Quality of life, Complications- bleeding, perforation, peritonitis, etc.
- Timepoint	Post-procedure, within 24 hours and 30 days, monthly

Study Results and Publication Information

Result Registerd

Sharing of Study Data Information

Sharing Statement	Not provided at time of Registration