Skip to content

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 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004308
Enrollment
40
Registered
2010-10-01
Start date
2010-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Branch duct type Intraductal papillary mucinous neoplasms

Interventions

administration of sulindac (150mg twice daily) placebo

Sponsors

Fourth Department of Internal Medicine, Sapporo medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
change of branch duct diameter

Countries

Japan

Contacts

Public ContactTsuyoshi Hayashi

Sapporo Medical University Fourth Department of Internal Medicine

thayashi69@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026