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Spots Global Cancer Trial Database for Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer

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Trial Identification

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

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

Study ID: NCT01111591

Study Description

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

Detailed Description: 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

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ho-Seong Han, Seonnam City, Gyeon gi do, Korea, Republic of

Contact Details

Name: Ho-Seong Han, Professor

Affiliation: General surgery department

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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