UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010012 |
|---|---|
| Receipt number | R000011727 |
| Scientific Title | A multicenter randomized trial of endoscopic papillary large balloon dilation alone versus endoscopic sphincterotomy for removal of bile duct stones |
| Date of disclosure of the study information | 2013/02/12 |
| Last modified on | 2015/08/26 22:18:49 |
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Basic information
Public title
A multicenter randomized trial of endoscopic papillary large balloon dilation alone versus endoscopic sphincterotomy for removal of bile duct stones
Acronym
MARVELOUS Trial
Scientific Title
A multicenter randomized trial of endoscopic papillary large balloon dilation alone versus endoscopic sphincterotomy for removal of bile duct stones
Scientific Title:Acronym
MARVELOUS Trial
Region
| Japan |
Condition
Condition
Bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Step 1
To compare the efficacy and safety of EPLBD alone versus EST for removal of bile duct stones.
Step 2
To compare the recurrence rate of bile duct stones and incidence of biliary infections.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Step 1
The rate of complete stone removal in the first session
Step 2
Long-term outcomes after EPLBD alone versus EST
Key secondary outcomes
Step 1
1)Usage of mechanical lithotripsy
2)Stone removal time
3)Complete stone clearance rate
4)Early complication rates
5)Cost effectiveness
Step 2
Late complication rates and stone recurrence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EPLBD without EST
Interventions/Control_2
EST
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with large CBD stones(maximum stone size is greater than or equal to 10 mm), and the diameter of the distal common bile duct is greater than or equal to 12 mm
2) greater than or equal to 60 years old
3) Patients with written informed consent
Key exclusion criteria
1) Patients with previous EST or EPBD
2) Patients after gastrectomy with Roux-en-Y reconstruction or Billroth II reconstruction
3) Patients with biliary strictures
4) Patients with acute pancreatitis
5) Patients with severe acute cholangitis
6) Patients with uncontrolled coagulopathy (e.g., LC, ESRD, etc.)
7) Patients considered ineligible for this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Faculty of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bukyo-ku, Tokyo
TEL
03-3815-5411
isayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuhei Kawahata, Hirofumi Kogure |
Organization
Faculty of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bukyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
kawahata-hok@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
1. 東京大学医学部附属病院（東京都） 1. The University of Tokyo Hospital (Tokyo)
2. 北海道大学病院（北海道） 2. Hokkaido University Hospital (Hokkaido)
3. 札幌医科大学附属病院（北海道） 3. Sapporo Medical University Hospital(Hokkaido)
4. 横浜市立大学附属病院（神奈川県） 4. Yokohama City University Hospital (Kanagawa)
5. 旭中央病院（千葉県） 5. Asahi General Hospital (Chiba)
6. JA尾道総合病院（広島県） 6. JA Onomichi General Hospital (Hiroshima)
7. 名古屋第二赤十字病院（愛知県） 7. Japanese Red Cross Nagoya Daini Hospital (Aichi)
8. 岐阜大学医学部附属病院（岐阜県） 8. Gifu University Hospital (Gifu)
9. 岐阜市民病院（岐阜県） 9. Gifu Municipal Hospital (Gifu)
10. 昭和大学横浜市北部病院（神奈川県） 10. Showa University Northern Yokohama Hospital (Kanagawa)
11. せんぽ東京高輪病院（東京都） 11. Sempo Tokyo Takanawa Hospital (Tokyo)
12. 日本赤十字社医療センター（東京都） 12. Japanese Red Cross Medical Center (Tokyo)
13. JR東京総合病院（東京都） 13. JR Tokyo General Hospital (Tokyo)
14. 関東中央病院（東京都） 14. Kanto Central Hospital (Tokyo)
15. 東京警察病院（東京都） 15. Tokyo Metropolitan Police Hospital (Tokyo)
16. 三井記念病院（東京都） 16. Mitsui Memorial Hospital (Tokyo)
17. 群馬大学医学部附属病院（群馬県） 17. Gunma University Hospital (Gunma)
18. 岡山大学病院（岡山県） 18. Okayama University Hospital (Okayama)
19. 久留米大学病院（福岡県） 19. Kurume University Hospital (Fukuoka)
20. 埼玉医科大学国際医療センター(埼玉県)20. Saitama Medical University International Medical Center
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 12 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 12 | Day |
Last modified on
| 2015 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011727
