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

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 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


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

Value
https://center6.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