UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041343 |
|---|---|
| Receipt number | R000047201 |
| Scientific Title | Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2026/05/02 15:26:25 |
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Basic information
Public title
EUS-Guided Choledochoduodenostomy Using Covered Self-Expandable Metallic Stents with a Thin Delivery System Versus ERCP for First-Line Biliary Drainage in Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Trial
Acronym
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography for malignant distal bile duct obstruction: A multicenter randomized controlled trial
Scientific Title
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial
Scientific Title:Acronym
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography for malignant distal bile duct obstruction : A multicenter randomized controlled trial
Region
| Japan |
Condition
Condition
A malignant distal biliary obstruction that is unresectable or presents a very high surgical risk
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare first-line biliary drainage for malignant distal bile duct obstrucion between ultrasonic endoscopic biliary drainage and transpapillary biliary drainage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Stent patency rate at 180 days after treatment
Key secondary outcomes
Procedure success rate, clinical improvement rate, incident rate, procedure time, success rate of re-intervention, rate of successful stenting without dilatation (EUS-BD group only), survival time, and percentage of post-drainage chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transpapillary biliary drainage (ERCP)
Interventions/Control_2
Endoscopic ultrasound biliary drainage (EUS-BD)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years old or over
2) Radiological diagnosis (with or without pathological confirmation) of malignancy, and presence of a malignant distal biliary obstruction and dilation of the upstream bile duct that is unresectable or presents a very high surgical risk
3) Written consent obtained following adequate explanation of the study aims, design, and procedures.
Key exclusion criteria
1) Radiological evidence of gastric outlet obstruction on CT,
2) Hilar biliary obstruction,
3) Surgically altered anatomy
4) ECOG performance status of 4,
5) Poorly controlled ascites,
6) History of endoscopic sphincterotomy (EST),
7) Biliary stenting,
8) Serious complication involving another organ,
9) Uncorrectable coagulopathy and/or thrombocytopenia,
10) Any other condition or situation determined by a study investigator to represent a reason for ineligibility.
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama-Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama city
TEL
073-441-0627
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Itonaga |
Organization
Wakayama-Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama city
TEL
073-441-0627
Homepage URL
kitano@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama-Medical University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Wakayama Medical University
Address
Kimiidera 811-1, Wakayama city
Tel
0734472300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
95
Results
Ninety-three patients were analyzed (ERCP, n=47; CDS, n=46). The 180-day RBO rate did not differ significantly between groups (19.4% vs 14.5%, P=0.432). Compared with ERCP, CDS had a shorter procedure time (15 vs 30 min, P=0.002) and hospital stay (11 vs 16 days, P=0.049). Technical and clinical success rates were comparable.
Results date posted
| 2026 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Enrollment was considered for consecutive patients 20 years old or older who had a radiologic diagnosis of malignancy (with or without pathological confirmation) and malignant distal biliary obstruction with upstream bile duct dilatation, and who were deemed unresectable or at very high surgical risk.
Participant flow
Between October 2020 and January 2025, a total of 95 patients were enrolled (ERCP group, n=49; CDS group, n=46) (Figure 3). Two patients in the ERCP group did not receive the allocated intervention because they withdrew consent. Ultimately, 47 patients in the ERCP group and 46 patients in the CDS group were included in the analysis.
Adverse events
Early AEs occurred in 30% of patients in the ERCP group and 15% in the CDS group, with no significant difference between groups (P = 0.136). However, the rate of acute pancreatitis was significantly higher in the ERCP group than in the CDS group (15% vs. 0%, P = 0.012). In addition, early AEs of moderate or severe severity were significantly more common in the ERCP group than in the CDS group (21% vs. 4%, P = 0.027). No significant difference between groups was evident in terms of late AEs (P=1.000).
Outcome measures
The primary endpoint was the RBO rate at 180 days after stent insertion. Secondary endpoints were the technical success rate, clinical success rate, procedure-related adverse event rate, procedure time, reintervention success rate, time to recurrent biliary obstruction (TRBO), overall RBO rate, post-drainage chemotherapy rate, technical success rate without a tract dilation device (CDS group), and overall survival (OS).
Plan to share IPD
There is no plan to share individual participant data because data sharing with external researchers was not specified in the informed consent documents or the approved study protocol.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047201
