Trial Information
Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice
Inclusion Criteria:
- patient who have periampullary tumors causing obstructive jaundice
- patient age: ≥20 and ≤85
- resectable state of disease
- no history of previous chemotherapy or radiotherapy
- patients without uncontrollable severe cardiovascular, respiratory disease
- Karnofsky performance scale ≥70
- informed consent
Exclusion Criteria:
- patients with distant metastasis or locally advanced disease with major vascular
invasion
- duodenal cancer
- biliary drainage before randomization
- previous chemotherapy or radiotherapy
- uncontrollable active infection except cholangitis
- severe comorbid disease (cardiac, pulmonary, cerebrovascular)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of infectious complications after biliary drainage
Outcome Description:
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Outcome Time Frame:
within 120 days after drainage
Safety Issue:
Yes
Authority:
Korea: Institutional Review Board
Study ID:
H-1001-047-307
NCT ID:
NCT01134276
Start Date:
August 2010
Completion Date:
December 2013
Related Keywords:
- Periampullary Cancers Causing Obstructive Jaundice
- Pancreas Head Cancer
- Bile Duct Cancer
- Ampulla of Vater Cancer
- Jaundice
- Jaundice, Obstructive
- Bile Duct Neoplasms
- Head and Neck Neoplasms