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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010012
Receipt No. 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

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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
Email 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
Email kawahata-hok@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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