Skip to content

  • About CRIS
  • Search
    • Basic Search
    • Advanced Search
    • Search by Topics
      • Condition(s)/Problem(s)
      • Intervention Type
      • Phase
    • Recently Registered
    • Recently Updated
  • FAQ
  • Statistics
  • Registration Data Set

Contact Us

criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2014/10/08
    • Registered Date : 2015/02/02
    • Last Updated Date : 2016/07/19
Background Information
1.Background  
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
2. Institutional Review Board/Ethics Committee  
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
3.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
4. Status 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
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Ministry of Health & Welfare 
- Organization Type Government  
- Project ID HI14C0139 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Asan Medical Center  
- Organization Type Medical Institute  
Study Summary
7. 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
8. Study Design  
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
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
9. Subject  
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
10. Outcome Measure(s)  
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
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration