UMIN-CTR Clinical Trial

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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