Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer
NCT ID: NCT01111591
Last Updated: 2016-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
220 participants
INTERVENTIONAL
2008-11-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Extrahepatic bile duct cancer : 55 patients for administration of COX2 55 patients for control group
* Pancreas cancer : 55 patients for administration of COX2 55 patients for control group
Indication
* After operation of extrahepatic bile duct cancer or pancreas cancer
* Age : 19 - 70 years old
* The patients who agree to consent sheet.
Contraindication
* Impossible of administration due to severe postoperative morbidities (bleeding, bowel obstruction, pancreatic fistula, biliary fistula)
* Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP\>160)
* Renal insufficiency: CCR \< 50 or serum creatinin \>3.0
* Hepatic insufficiency: Liver cirrhosis or active hepatitis
* Preexisting allergic reaction history for NSAIDs or Sulfonamide
* Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
* Preexisting Asthma. Especially aspirin-sensitive asthma.
* Contraindications to aspirin, clopidogrel or celecoxib
* The patients who refuse trial
* The patients who has Psychogenic problem
Allocation
* We will allocate patients randomly, to administration group or control group
Methods
* From postoperative third day, administration will be started
* celecoxib 200mg bid for 6 months for administration group
* Follow up and assess recurrence rate and survival rate
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2. Bile duct cancer - control
Bile duct cancer patients do not administration of COX inhibitor
No interventions assigned to this group
3. Pancreas cancer - experimental
Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
4. Pancreas cancer - control
Pancreas cancer patients do not administration of COX inhibitor
No interventions assigned to this group
Bile duct cancer - experimental
Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Between 19 and 70 years old
* Agreed to consent sheet
Exclusion Criteria
* Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP\>160)
* Renal insufficiency: CCR \< 50 or serum creatinin \>3.0
* Hepatic insufficiency: Liver cirrhosis or active hepatitis
* Preexisting allergic reaction history for NSAIDs or Sulfonamide
* Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
* Preexisting Asthma. Especially aspirin-sensitive asthma.
* Contraindications to aspirin, clopidogrel or celecoxib
* When patients refused
* Patients has psychological problem
19 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ho-Seong Han
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ho-Seong Han, Professor
Role: STUDY_CHAIR
General surgery department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ho-Seong Han
Seonnam City, Gyeon Gi Do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Koo BK, Kim YS, Park KW, Yang HM, Kwon DA, Chung JW, Hahn JY, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Chung WY, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Effect of celecoxib on restenosis after coronary angioplasty with a Taxus stent (COREA-TAXUS trial): an open-label randomised controlled study. Lancet. 2007 Aug 18;370(9587):567-74. doi: 10.1016/S0140-6736(07)61295-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B-0712-052-006 (local IRB)
Identifier Type: OTHER
Identifier Source: secondary_id
SNUBH-GS-HBP2
Identifier Type: -
Identifier Source: org_study_id