Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 211
- Locations
- 1
- Primary Endpoint
- Incidence of Infectious Complications After Biliary Drainage
Study Overview
Brief Summary
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
PTBD
biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
Intervention: biliary drainage (Procedure)
ERBD
biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer
Intervention: biliary drainage (Procedure)
Outcomes
Primary Outcomes
Incidence of Infectious Complications After Biliary Drainage
Time Frame: within 120 days after drainage
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Secondary Outcomes
- Change in Total Serum Bilirubin After Drainage(within 14 days after drainage)
- Total Hospital Cost During Admission After Biliary Drainage(during hospital stay for biliary drainage procedure)
Investigators
Sun-Whe Kim
Professor
Seoul National University Hospital