Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer

Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.

In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.

Patients : total 220 patients 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

From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.

Inclusion Criteria: The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer Between 19 and 70 years old Agreed to consent sheet Exclusion Criteria: The patients cannot administration of drug due to severe postoperative morbidities. 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

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. Erratum In: Lancet. 2007 Sep 14;370(9590):828.