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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

Status Approved

First Submitted Date

2014/10/08
Registered Date

2015/02/02
Last Updated Date

2016/07/19

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
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

2. Institutional Review Board / Ethics Committee

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
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	Yes The Institutional Review Board at the University of Soonchunhyang University

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
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

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
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
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2014-10-06 ,
Recruitment Status by Participating Study Site 2
Name of Study	Soon Chun Hyang University Hospital Cheonan
Recruitment Status	Completed
Date of First Enrollment	2014-10-06 ,
Recruitment Status by Participating Study Site 3
Name of Study	Pusan National University Hospital
Recruitment Status	Completed
Date of First Enrollment	2014-11-24 ,
Recruitment Status by Participating Study Site 4
Name of Study	Dankook Univeristy Hospital
Recruitment Status	Completed
Date of First Enrollment	2014-11-19 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	HI14C0139

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
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 Summary Information

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.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
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.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C24.9)Malignant neoplasm of biliary tract, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~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

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
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

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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