N/A
N=211
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Periampullary Cancers With Obstructive Jaundice · Pancreas Head Cancer · Bile Duct Cancer · Ampulla of Vater Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01134276 ↗Enrolled (actual)
211
Serious AEs
24.6%
Results posted
Jun 2014
Primary outcome: Primary: Incidence of Infectious Complications After Biliary Drainage — 11; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- biliary drainage (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Infectious Complications After Biliary Drainage |
11; 5 | — |
| SECONDARY Change in Total Serum Bilirubin After Drainage |
0.7; 0.6 | — |
| SECONDARY Total Hospital Cost During Admission After Biliary Drainage |
16.0; 17.0 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01134276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.