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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004308
Receipt No. R000005055
Scientific Title A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
Date of disclosure of the study information 2010/10/01
Last modified on 2014/04/01

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Basic information
Public title A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
Acronym A randomized, double-blind, placebo-controlled trial for effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
Scientific Title A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
Scientific Title:Acronym A randomized, double-blind, placebo-controlled trial for effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
Region
Japan

Condition
Condition Branch duct type Intraductal papillary mucinous neoplasms
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluating of suppressive effect of sulindac on BD-IPMNs
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of branch duct diameter
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of sulindac (150mg twice daily)
Interventions/Control_2 placebo
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. There is grape-like cystic dilatation of pancreatic branch duct.
2. Pancreatogram or duodenoscope revealed the existence of mucin, or the cystic lesion was pathologically proven IPMN.
3. Patients fully understand and are willing to give a written informed consent about participation.
Key exclusion criteria 1. The lesion was histologically or cytologically proven malignant.
2. Imaging modality revealed suspicious findings of invasion derived from IPMN.
3. Imaging modality revealed coexistence of pancreatic ductal cancer.
4. Imaging modality revealed mural nodule, which is 10 mm or more.
5. Regular use of NSAIDs.
6. Allergy to NSAIDs.
7. Active peptic ulcer.
8. Severe hematological disturbance, liver damage, renal dysfunction or heart failure.
9. Past history of aspirin- or NSAIDs-induced asthma.
10. Creatinine >= 1.5 mg/dl.
11. Allergy to contrast medium.
12. Patient cannot have MRI because of implantation of metal or pacemaker.
13. Patients with lactation or pregnancy.
14. Patient with coinciding active malignancies.
15. Patient with active infection.
16. ECOG performance status is 3 or 4.
17. Patient with disturbance of consciousness (Japan coma scale >= I-1).
18. Patient who was considered ineligible based on decision of a reasonable investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Hayashi
Organization Sapporo medical university
Division name Fourth Department of Internal Medicine
Zip code
Address South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.
TEL 011-611-2111
Email thayashi69@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Hayashi
Organization Sapporo Medical University
Division name Fourth Department of Internal Medicine
Zip code
Address S1, W16, Chuoku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email thayashi69@sapmed.ac.jp

Sponsor
Institute Fourth Department of Internal Medicine, Sapporo medical university
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 10 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
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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 01 Day
Last modified on
2014 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005055

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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