Unique ID issued by UMIN | UMIN000004308 |
---|---|
Receipt number | 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 20:47:58 |
A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
A randomized, double-blind, placebo-controlled trial for effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
A randomized, double-blind, placebo-controlled trial for effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms
Japan |
Branch duct type Intraductal papillary mucinous neoplasms
Hepato-biliary-pancreatic medicine |
Others
NO
evaluating of suppressive effect of sulindac on BD-IPMNs
Efficacy
change of branch duct diameter
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
administration of sulindac (150mg twice daily)
placebo
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
40
1st name | |
Middle name | |
Last name | Tsuyoshi Hayashi |
Sapporo medical university
Fourth Department of Internal Medicine
South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.
011-611-2111
thayashi69@sapmed.ac.jp
1st name | |
Middle name | |
Last name | Tsuyoshi Hayashi |
Sapporo Medical University
Fourth Department of Internal Medicine
S1, W16, Chuoku, Sapporo, Hokkaido, Japan
011-611-2111
thayashi69@sapmed.ac.jp
Fourth Department of Internal Medicine, Sapporo medical university
none
Self funding
NO
2010 | Year | 10 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 09 | Month | 14 | Day |
2010 | Year | 10 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
Value
https://center6.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 |