UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001427 |
|---|---|
| Receipt number | R000001732 |
| Scientific Title | Randomized controlled trial of the ESWL combined with endoscopic treatment for preventive effect on progression of chronic pancreatitis |
| Date of disclosure of the study information | 2008/10/11 |
| Last modified on | 2014/04/21 13:01:06 |
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Basic information
Public title
Randomized controlled trial of the ESWL combined with endoscopic treatment for preventive effect on progression of chronic pancreatitis
Acronym
Efficacy of ESWL/Endoscopic treatment for chronic pancreatitis
Scientific Title
Randomized controlled trial of the ESWL combined with endoscopic treatment for preventive effect on progression of chronic pancreatitis
Scientific Title:Acronym
Efficacy of ESWL/Endoscopic treatment for chronic pancreatitis
Region
| Japan |
Condition
Condition
chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ESWL combined with endoscopic treatment has shown to be effective for painful chronic pancreatitis. However, there has been no evidence whether these intervention is preventative for the progressionof chronic pancreatitis. Here, we examined the efficacy of ESWL/Endoscopic treatment in preventing the progression of chronic pancreatitis by randomized contrilled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
recurrence of pancreatic symptoms
Key secondary outcomes
Morphological change in the pancreas, Endocrine and exocrine function of the pancreas, survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
ESWL combined with endoscopic pancreatic lithotripsy
Interventions/Control_2
No intervention
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Mild pancreatic symptoms
2)MPD stones in head/body of the pancreas
without atrophy in the tail of the pancreas
4)No previous intervention for pancreatic stone
5)No daily steatorrhea
6)No diabetes with insulin
Key exclusion criteria
1)multiple pseudocyst
2)Contraindication for ESWL(AAA, Pacemaker)
3)daily abuse of alcohol
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Sasahira |
Organization
Faculty of Medicine, University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
sasahira-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Sasahira |
Organization
Faculty of Medicine, University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
sasahira-tky@umin.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 11 | 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
Completed
Date of protocol fixation
| 2007 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 11 | Day |
Last modified on
| 2014 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001732
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
